Clinical Studies

Acute Bleeds

2024

‘Efficacy and safety of endoscopic hemostasis with a self-assembling peptide solution in patients with colonic diverticular bleeding: a multicenter pilot study’
Yamaguchi, Daisuke et al. Gastrointestinal Endoscopy, Volume 0, Issue 0. (2024). [Read]

2023

‘Emergency Endoscopic Haemostasis for Gastrointestinal Bleeding using A Self-Assembling Peptide: A Case Series’
Murakami T., Kamba E., Haga K., Akazawa Y., Ueyama H., Shibuya T., Hojo M., Nagahara A. Preprints.org, 2023030459. [Read]
‘Endoscopic Hemostatic Treatment for Acute Gastrointestinal Bleeding by Combined Modality Therapy with PuraStat and Endoscopic Hemoclips’
Kubo K., Hayasaka S., Tanaka I. Case Rep Gastroenterol. 2023 Feb 7;17(1):89-95. [Read]
‘Efficacy of a novel self-assembling peptide gel for hemostasis in refractory neoplastic bleeding’
Kano Y, Sunakawa H, Nakajo K, Kadota T, Yano T. VideoGIE. 2023 Jun 12;8(8):307-309. PMID: 37575138; PMCID: PMC10422049. [Read]

More studies

2022

‘A case of gastric antral vascular ectasia in which PuraStat, a novel self-assembling peptide hemostatic hydrogel, was effective’
Misum Y. et al. 2022. DEN Open 10;3(1):e183. PMID: 36381641; PMCID: PMC9647830. [Read]
‘Using a self-assembling peptide to achieve endoscopic hemostasis for anastomotic bleeding after ileocecal resection’
Ikoma I., Murakami T., Haga K., Yatagai N., Ueyama H., Shibuya T., Nagahara A. 2022. Endosc Int Open 2022;10:E921–E922 [Read]

2021

‘PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study.’
Branchi F., Klingenberg-Noftz R., Friedrich K. et al. 2021. Surg Endosc. [Read]
‘Endoscopic Application of PuraStat in the Treatment of Solitary Rectal Ulcer Syndrome’
Gagliardi M., Sica M., Oliviero G., Maurano A. and Zulli C. 2021. Journal of Gastrointestinal and Liver Diseases. [Read]

2020

‘Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding.’
de Nucci G., Reati R., Arena I., Bezzio C., Devani M., Corte C., Morganti D., Mandelli E., Omazzi B., Redaelli D., Saibeni S., Dinelli M., Manes G. 2020. Endoscopy. [Read]

ERCP

2024

'Prophylactic use of a self-assembling peptide hydrogel for preventing delayed bleeding after endoscopic sphincterotomy: A propensity score-matched analysis'
Inoue, T., et al., Journal of Gastroenterology and Hepatology. 2024. [Read ]
'Meta-Analysis and Systematic Review of the Emerging use of PuraStat as Hemostatic Agent for Post-Sphincterotomy Bleeding'
Kishore, M., Khan, Z. H., & Puli, S. (2024). S132. The American Journal of Gastroenterology, 119(10S), S99. [Read ]
'Step Up Strategy For Endoscopic Hemostasis Using a Self Assembling Peptide Hemostatic Gel After Endoscopic Sphincterotomy Bleeding A Prospective Trial'
Ogura T, Okuda A, Uba Y, and Nishikawa H. Digestive Disease Week 2024, Washington, United States of America [Read ]
'Prospective Observational Study of a Novel Self-Assembling Peptide Hemostatic Gel for Initial Hemostasis in Endoscopic Sphincterotomy-Related Hemorrhage'
Ishida Y, Koga T, Tsuchiya N, Kitaguchi T, Matsumoto K, Fukuyama M, Kuno N, Funakoshi S, Ashizuka S & Hirai F 2024. Endoscopy [Read ]
‘Treatment of Postsphincterotomy Bleeding With a Novel Self-Assembling Peptide Hemostatic Gel’
Hrabak, P., Bruha, R., Petrtyl, J., & Stepanek, L. (2024c). Endoscopy. [Read ]

More studies

2023

‘Endoscopic Management Using Novel Haemostatic Agents for Immediate Bleeding during Endoscopic Retrograde Cholangio-Pancreatography’
Lesmana C.R.A., Sandra S., Paramitha M.S., Gani R.A., Lesmana L.A. Canadian Journal of Gastroenterology and Hepatology. 5212580. [Read]
‘Delayed bleeding after precut sphincterotomy successfully treated with a novel self-assembling peptide gel’
Kubo K., Hayasaka S., Kitaguchi Tanaka I. 2023. Gastrointest. Endosc., 97(2), pp. 374-376. [Read]
‘Successful hemostasis using a self-assembling peptide hydrogel for bleeding after endoscopic papillary large-balloon dilation’
Inoue T., Ibusuki M., Kitano R., Kobayashi Y., Ito K., Yoneda M. Endoscopy, 55(Suppl 1), pp. E555-E556. [Read]

2022

‘Comparison of Endoscopic Haemostasis for Endoscopic Sphincterotomy Bleeding between a Novel Self-Assembling Peptide and Conventional Technique’
Uba Y., Ogura T., Ueno S., Okuda A., Nishioka N., Miyano A., Yamamoto Y., Bessho K., Tomita M., Nakamura J., Hakoda A., Nishikawa H. Journal of Clinical Medicine, 12(1), pp. 79. [Read]
‘A novel self-assembling peptide hemostatic gel as an option for initial hemostasis in endoscopic sphincterotomy-related hemorrhage: a case series’
Ishida Y., Tsuchiya N., Koga T., Kitaguchi T., Matsumoto K., Kuno N., Funakoshi S., Ishibashi H., Ashizuka S., Hirai F. Clin J Gastroenterol. 15(6), pp. 1210-1215. [Read]
‘Novel Haemostatic Gel As Rescue Therapy for Postsphincterotomy Bleeding Refractory to Self-Expanding Metallic Stent Placement.’
Gagliardi M. et al. ACG Case Reports Journal. 9(1). [Read]
‘Use of a novel self-assembling hemostatic gel as a complementary therapeutic tool for endoscopic sphincterotomy-related bleeding’
Yamamoto K., Sofuni A., Mukai S., Matsunami Y., Kojima H., Hirakawa N., Itoi T. J Hepatobiliary Pancreat Sci. 29(9), pp. e81-e83. [Read]

Radiation Proctopathy

2023

‘Successful treatment of hemorrhagic chronic radiation proctopathy with a novel self-assembling peptide.’
Cavlina Sevo M., Markos P., Bradić T., Bilic B., Rustemovic N., Grubelic Ravic K., Krznarić Ž., Kalauz M. 2023. ePoster Endoscopy 2023; 55(S 02): S155. [Read]

2021

‘PWE-048 Endoscopically-delivered PuraStat for the treatment of severe haemorrhagic radiation proctopathy: A case series.’
White K. and Henson, C. Gut, 68, A195-A196. [Read]

More studies

2020 and earlier

‘Outcomes from the UK PuraStat Registry- A Multicentre Prospective Observational Study to Evaluate the Role of PuraStat in the Management of Gastrointestinal Bleeding (POPS).’
Arndtz S., Subramaniam S., Hossain E., Abdelrahim M., Ang Y., Beintaris I., di Pietro M., Iacucci M., Saunders B., Suzuki N., Bhandari P. [Abstract presentation (virtual) ESGE Days Congress 23rd-25th April 2020] Endoscopy. 52: S1–S350 [Read]
‘Endoscopically delivered PuraStat for the treatment of severe haemorrhagic radiation proctopathy: a service evaluation of a new endoscopic treatment for a challenging condition.’
White K., Henson C. 2020. Frontline Gastroenterology. [Read]

Resection (Intraprocedural and Delayed Bleeding)

2024

'Efficacy of novel endoscopic hemostatic agent for bleeding control and prevention: Results from a prospective, multicenter national registry'

Maselli, R., et al., Endoscopy International Open, 12(10), E1220–E1229. (2024). [Read]
'Systematic review of self-assembling peptides as topical agents for treatment and prevention of gastrointestinal bleeding'

Voiosu A, State M, Drăgan V, Văduva S, Bălănescu P, Mateescu RB, Voiosu T. 2024. Clin Endosc. [Read]
‘Efficacy of hemostatic gel for perioperative bleeding and prevention of delayed bleeding of cold snare polypectomy under anticoagulant’.
Yoshida N., Dohi O., Inagaki Y., Tomita Y., Hashimoto H., Kobayashi R., Inoue K., Hirose R., Morimoto Y., Inada Y., Murakami T., Itoh Y., 2024. JGH Open. [Read]
'A self-assembling peptide reduces delayed bleeding after endoscopic submucosal dissection in the colorectum - a retrospective single center cohort study'
Schmutte L., Ulrch J., Wießner J.R., Heilmaier M., Schlag C., Abdelhafez M., 2024. Endoscopy 2024; 56(S 02):S122 [Read]

More studies

2023

‘Efficacy of self-assembling peptide in mitigating delayed bleeding after advanced endoscopic resection of gastrointestinal lesions. A meta-analysis.’
Gopakumar H., Vohra I., Sharma N., Puli S.R. Endoscopy International Open. [Read]

‘Hemospray versus Purastat for the management of acute gastrointestinal bleeding & prophylaxis of post-polypectomy bleeding: a large US academic Cancer centrer experience’.
Al-Bustami l.S., Nakshabandi A., Coronel E., Ge P. Abstract presented at ACG (US) on October, 23rd-25th. [Read]

‘New Alternative? Self-Assembling Peptide in Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis’.
Dhindsa B.S., Tun K.M., Scholten K.J., Deliwala S., Naga Y., Dhaliwal A., Ramai D., Saghir S.M., Dahiya D.S., Chandan S., Singh S., Adler D.G. Digestive diseases and sciences, 68(9), 3694–3701. [Read]
‘Outcomes from the UK PuraStat Registry- A Multicentre Prospective Observational Study to Evaluate the Role of PuraStat in the Management of Gastrointestinal Bleeding (POPS).’
Arndtz S., Subramaniam S., Hossain E., Abdelrahim M., Ang Y., Beintaris I., di Pietro M., Iacucci M., Saunders B., Suzuki N., Bhandari P. [Abstract presentation (virtual) ESGE Days Congress 23rd-25th April 2020] Endoscopy. 52: S1–S350.
‘A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial.’
Subramaniam S., Kandiah K., Chedgy F., Fogg C., Thayalasekaran S., Alkandari A., Baker-Moffatt M., Dash J., Lyons-Amos M., Longcroft-Wheaton G., Brown J., Bhandari P. 2020. Endoscopy. Online ahead of print. (1):155‐162. PMID: 32679602. [Read]
‘Application of a novel self‑assembling peptide to prevent hemorrhage after EMR, a feasibility and safety study.’
Soons E., Turan A., van Geenen E., Siersema P. 2020. Surgical Endoscopy. Online ahead of print. PMID: 32804267 [Read]
‘Haemostasis and prevention of bleeding related to ER: The role of a novel self-assembling peptide.’
Subramaniam S., Kandiah K., Thayalasekaran S., Longcroft-Wheaton G., Bhandari P. 2019. United European Gastroenterology Journal, 7(1), pp.155-162. [Read]
‘Bleeding during Endoscopic Submucosal Dissection: A Randomised Controlled Trial of a Novel Haemostatic Agent.’
Subramaniam S., Kandiah K., Thayalasekaran S., Longcroft-Wheaton G. and Bhandari P. 2017. United European Gastroenterology Journal, 6. [Read]
‘Minimising the risk of delayed bleeding in colonic endoscopic submucosal dissection: Is there a role for a novel haemostatic peptide?.’
Subramaniam S., Kandiah K., Fujimoto A., Yahagi N., Uraoka T., Bhandari P. 2017. United European Gastroenterology Journal, 5, pp.A1-A160. [Read]
‘A self-assembling matrix-forming gel can be easily and safely applied to prevent delayed bleeding after endoscopic resections.’
Pioche M., Camus M., Rivory J., Leblanc S., Lienhart I., Barret M., Chaussade S., Saurin J., Prat F., Ponchon T. 2016. Endoscopy International Open, 04(04), pp.E415-E419. [Read]
‘Initial clinical trial of a novel haemostat, TDM-621, in the endoscopic treatments of the gastric tumors’
Yoshida M., Goto N., Kawaguchi M., Koyama H., Kuroda J., Kitahora T., Iwasaki H., Suzuki S., Kataoka M., Takashi F., Kitajima M. 2014. J Gastroenterol Hepatol. 29(4), pp. 77-79. [Read]

Pancreatic Necrosectomy

2023

‘The Use of PuraStat in the Management of Walled-Off Pancreatic Necrosis Drained Using Lumen-Apposing Metal Stents: A Case Series’
Binda C., Fugazza A., Fabbri S., Coluccio C., Repici A., Tarantino I., Anderloni A., Fabbri C. Medicina, 59(4), pp. 750. [Read]
‘Novel hemostatic option using self-assembling peptide gel for endoscopic necrosectomy-related bleeding’
Takehiko K., Ishida Y., Tsuchiya N., Kitaguchi T., Kurogi T., Shimoji Y., Hirai F. Endoscopy 55(S 01), pp. E598-E599. [Read]
‘Haemostatic matrix for treating intra-collection bleeding after EUS-drainage and endoscopic necrosectomy of a WOPN in a cirrhotic patient’
Rizzo G.E. M., Ligresti D., Carrozza L., Salvatore T., Traina M., Tarantino I. Endoscopy 2023; 55(S 02): S155. [Read]

Colorectal

‘Self-assembling peptide haemostatic gel reduces incidence of pelvic collection after total mesorectal excision: Prospective cohort study’
Stefan S, Wagh M, Siddiqi N, Naqvi S, Rawlinson E, Shepherd A, Khan J. 2021. Annals of Medicine and Surgery. v68:102553. [Read]
‘Safety and feasibility of PuraStat in laparoscopic colorectal surgery (Feasibility study)’
Ortenzi, M. & Haji, A. 2020. Minimally Invasive Therapy & Allied Technologies. [Read]

General

‘Endoscopic Hemostasis of a Pleural Hemorrhage using a Hemostatic Gel’
Negreanu L., Chirculescu F., Goran L. 2019. Journal of Gastrointestinal and Liver Diseases, 28(2), pp. 148-148. [Read]

Gynaecology

‘Efficacy and feasibility of the RADA16 self-assembling peptide, PuraStat for haemostasis in laparoscopic gynaecological surgery: a pilot study’
Hall P. 2024. The Australian and New Zealand Journal of Obstetrics and Gynaecology 2024. [Read]

Liver

‘A multi-center postmarket clinical study to confirm safety and performance of PuraStat in the management of bleeding during open liver resection’
Nahm C.B., Popescu I., Botea F., Fenwick S., Fondevila C., Bilbao I., Reim D., Toogood G.J. 2021. HPB. [Read]

Partial Nephrectomy

‘Effectiveness of a new haemostatic agent in robotic partial nephrectomy’
Sarhan, A., & Chakravarti, A. 2024. [Poster]. 21st Annual Meeting of the EAU Robotic Urology Section, Bordeaux, France. [Read]
‘Comparison between Tisseel and PuraStat as a hemostatic material in robot assisted and laparoscopic partial nephrectomies’
Femic A., Haggman M., Ladjevardi S. 2021. Abstract MP28-12. JOURNAL OF ENDOUROLOGY, 35, Supp.1. [Read]

Prostatectomy

‘Innovative Use of RADA16 Self-Assembling Peptide (PuraBond®) as a Hemostatic Agent in Holmium Laser Enucleation of the Prostate (HoLEP): A Safety and Feasibility Study’
Sid Ahmed M., Nkwam N., (December 11, 2024). [Read]
‘A transparent synthetic peptide hydrogel as a haemostatic agent in athermal nerve sparing robot-assisted radical prostatectomy: an observational study’
Munien K., Harrison W., Paul J., Desai D. 2023. Transl Androl Urol. 12(11):1658-1665 [Read]

Holmium Laser Enucleation (HoLEP)

‘Innovative Use of RADA16 Self-Assembling Peptide (PuraBond®) as a Hemostatic Agent in Holmium Laser Enucleation of the Prostate (HoLEP): A Safety and Feasibility Study’
Sid Ahmed M., Nkwam N., (December 11, 2024). [Read]

Radiation Cystitis

‘Cystoscopic application of PuraStat® in the treatment of radiation-induced haemorrhagic cystitis
Darwazeh H, Hemsworth L, Smith L, Ilie PC. Ann R Coll Surg Engl. Published online February 16, 2024 [Read]
‘Technique used for PuraStat® application in urinary bladder bleeding’
Ile P.C., Darwazeh H., Hemsworth L., Smith L. Atena Journal of Urology 2023: 3(1) [Read]

Ears, Nose & Throat

2024

‘Nasal Puragel Application Decreases Epistaxis Severity Scores in Adults with Hereditary Hemorrhagic Telangiectasia’
Im, E., Adelman., et al., (2024). Presented at the 15th HHT International Scientific Conference, Mandelieu-la-Napoule, France. [Abstract]
‘Application of the Self-Assembling Peptide Hydrogel RADA16 for Hemostasis during Tonsillectomy: A Feasibility Study’
Michaels, J., Kaleva, A. I., Bateman, L., Wakelam, O., & Stephens, J. (2024). [Read]
‘Efficacy of a RADA-16 peptide hydrogel versus chitosan-based polymer in improving patient comfort during postoperative debridement: A randomized controlled trial’
Hur K., Adili A., Tam B., Herrera K., Agarwal A., Rice D., Ference E., Wrobel B., Conley D. Int Forum Allergy Rhinol. 2024: 1-8 [Read]

2023

‘Use of a novel RADA-16 self-assembling peptide, in a Draf-III frontal sinusotomy’.
Pak K., Wu A., Tang D.M. Presented at ARS fall meeting in Nashville 2023. [Read]

More studies

2022

‘RADA16, a Self-Assembling Peptide (SAP) for Haemostasis in Nasal Endoscopic Surgery, a Case Series in Australia’
Soodin D., Chong S., Morrissey D., Ha J., Naidoo Y., Foreman A., Switajewski M., Robinson D., Sprague A., Bagot D’Arc M. Surgery & Case Studies: Open Access Journal. [Read]

2020 and earlier

‘Use of PuraStat, a novel haemostatic matrix based on self-assembling peptides in the prevention of nasopharyngeal adhesion formation’
Wong E, Ho J, Smith M, Sritharan N, Riffat F, Smith MC. Int J Surg Case Rep. 70: 227–229. [Read]
‘A novel haemostatic agent based on self-assembling peptides in the setting of nasal endoscopic surgery, a case series.’
Lee M., Ma Z., Ananda A. International Journal of Surgery Case Reports, 41, pp.461-464. [Read]

Head & Neck

2023

‘Comparison between PuraStat and SurgiFlo as haemostatic agents used in oncologic Transoral Robotic Surgery (TORS)’
Sahota B., Khan M., Jeong B., Takhar A., Hodge J.C., Krishnan S., Foreman A. Poster presented at BACO, The British Academic Conference of Otolaryngology, February 14-17. [View poster]
‘Utilisation of PuraBond in Trans-Oral Robotic Surgery (TORS) for Oropharyngeal Cancer’
Gupta K.K., Garas G., Idle M., Germain S., De M. Poster presented at BACO, The British Academic Conference of Otolaryngology, February 14-17. [Read]

2022

‘The use of self-assembling peptides (PuraStat) for hemostasis in cervical endocrine surgery. A real-life case series of 353 patients.’
Gangner Y., Bagot d’Arc M., Delin C. International Journal of Surgery Case Reports, 94. [Read]
‘Evaluating the role of the self-assembling topical haemostat PuraBond in Transoral Robotic Surgery (TORS) for oropharyngeal cancer: A case series’
Gupta K.K., Garas G., Idle M., Germain S., De M. Annals of Medicine and Surgery, 80. [Read]

Cardiac Surgery

‘A Multi-Centre, Single-Arm Clinical Study to Confirm Safety and Performance of PuraStat, for the Management of Bleeding in Elective Carotid Artery Surgery.’
Stenson K.M., Loftus I.M., Chetter I., Fourneau I., Cavanagh S., Bicknell C., Loftus P. Clin Appl Thromb Hemost. Jan-Dec;28:10760296221144307. [Read]
‘Safety and Performance of a Self-Assembling Peptide Haemostat for the Management of Bleeding after Left Ventricular Assist Device Implantation: Outcomes of a Post Market Clinical Follow-Up Study.’
Morshuis M., Schönbrodt M., Gummert J. The Journal of Heart and Lung Transplantation, 38(4), p.S194. [Read]
‘Feasibility of a novel, synthetic, self-assembling peptide for suture-line haemostasis in cardiac surgery.’
Giritharan S., Salhiyyah K., Tsang G., Ohri S. Journal of Cardiothoracic Surgery, 13(1). [Read]
‘Novel Infectious Agent-Free Hemostatic Material (TDM-621) in Cardiovascular Surgery.’
Masuhara H., Fujii T., Watanabe Y., Koyama N., Tokuhiro K. Annals of Thoracic and Cardiovascular Surgery, 18(5), pp.444-451. [Read]

Pre-clinical

‘Self-assembling RADA16 peptide hydrogel supports hemostasis, synechiae reduction, and wound healing in sheep model of endoscopic nasal surgery.’
Lee M.FL., Ananda A. 2022. Auris Nasus Larynx’ ISSN 0385-8146. [Read]
‘Comparison of PuraStat self-assembling peptide hydrogel versus mineral-based Hemospray for endoscopic hemostasis of upper and lower gastrointestinal lesions in pigs.’
Gil E.S. et al. Front. 2022. Gastroenterol. 2022;1:971353. doi: 10.3389/fgstr.2022.971353. [Read]
‘PuraStat RADA16 Self-Assembling Peptide Reduces Postoperative Abdominal Adhesion Formation in a Rabbit Cecal Sidewall Injury Model’
Gil E.S., Aleksi E., Spirio L. 2021. Front Bioeng Biotechnol. 9:782224. [Read]
‘Prevention of esophageal stricture after circumferential endoscopic submucosal dissection using a modified self-assembling peptide’
Oumrani S., Barret M., Beuvon F., Nicco C., Chêne C., Batteux F., Prat F. 2021. Diseases of the Esophagus 00,1–7. [Read]
‘Application of a self-assembling peptide matrix prevents esophageal stricture after circumferential endoscopic submucosal dissection in a pig model’
Oumrani S., Barret M., Bordacahar B., Beuvon F., Hochart G., Pagnon-Minot A., Coriat R., Batteux F., Prat F. 2019. Plos One. 14(3): e0212362. [Read]

Interested in undertaking a study?

We’re always excited to gain new data. If you’re interested in conducting a clinical study please do not hesitate to get in touch.

Alternatively, if you’re looking for a study in a particular area that isn’t listed above, please let one of our reps know!

^{1. PuraStat IFU-007 Rev 2, PuraStat IFU-011 Rev 2, PuraStat IFU-018 Rev 1
2. PuraBond IFU-009 Rev 2, PuraBond IFU-014 Rev 2, PuraBond IFU-020 Rev 1
3. PuraShield IFU-015 Rev 2, PuraShield IFU-21 Rev 1}

Select a clinical area

Acute Bleeds

ERCP

Radiation Proctopathy

Resection (Intraprocedural and Delayed Bleeding)

Pancreatic Necrosectomy

Colorectal

General

Gynaecology

Liver

Partial Nephrectomy

Prostatectomy

Holmium Laser Enucleation (HoLEP)

Radiation Cystitis

Ears, Nose & Throat

Head & Neck

Plastic Surgery

Cardiac Surgery

Pre-clinical

RADA-16 Studies

Interested in undertaking a study?