Clinical Studies

This page features some of our key clinical studies in multiple clinical areas.

For information on all the areas that our products are indicated for, please carefully read the Instructions for Use^1,2.

^{1. PuraStat IFU-007 Rev2;}^{2. PuraBond IFU-009 Rev2}

GI - Haemostatic Efficacy GI - ERCP GI - Haemorrhagic RP GI - Delayed Bleeding Cardiac and Vascular Ear Nose and Throat Additional Clinical Areas Pre-Clinical Studies Peptide Technology and RADA16

GI - Haemostatic Efficacy

Studies related to GI Endoscopy and Laparoscopy: Haemostatic efficacy

Binda, C., Fugazza A., Fabbri S., Coluccio C., Repici A., Tarantino I., Anderloni A., Fabbri C. 2023. ‘The Use of PuraStat in the Management of Walled-Off Pancreatic Necrosis Drained Using Lumen-Apposing Metal Stents: A Case Series’, Medicina, 59($), pp. 750. View online.
Murakami, T., Kamba E., Haga K., Akazawa Y., Ueyama H., Shibuya T., Hojo M., Nagahara A. 2023. ‘Emergency Endoscopic Haemostasis for Gastrointestinal Bleeding using A Self-Assembling Peptide: A Case Series’, Preprints.org, 2023030459. View online.
Takehiko K., Ishida Y., Tsuchiya N., Kitaguchi T., Kurogi T., Shimoji Y., Hirai F. 2023. ‘Novel hemostatic option using self-assembling peptide gel for endoscopic necrosectomy-related bleeding’, Endoscopy 55(S 01), pp. E598-E599. View online.
Gagliardi, M. et al. 2022. Novel Haemostatic Gel As Rescue Therapy for Postsphincterotomy Bleeding Refractory to Self-Expanding Metallic Stent Placement. ACG Case Reports Journal. 9(1). View study online
Ikoma I, Murakami T, Haga K, Yatagai N, Ueyama H, Shibuya T, Nagahara A. 2022. 'Using a self-assembling peptide to achieve endoscopic hemostasis for anastomotic bleeding after ileocecal resection' Endosc Int Open 2022; 10: E921–E922 View more info
Ishida Y., Tsuchiya N., Koga T., Kitaguchi T., Matsumoto K., Kuno N., Funakoshi S., Ishibashi H., Ashizuka S., Hirai F. 2022. ‘A novel self-assembling peptide hemostatic gel as an option for initial hemostasis in endoscopic sphincterotomy-related hemorrhage: a case series’, Clin J Gastroenterol. 15(6), pp. 1210-1215. View online.
Uba Y., Ogura T., Ueno S., Okuda A., Nishioka N., Miyano A., Yamamoto Y., Bessho K., Tomita M., Nakamura J., Hakoda A., Nishikawa H. 2022. Comparison of Endoscopic Haemostasis for Endoscopic Sphincterotomy Bleeding between a Novel Self-Assembling Peptide and Conventional Technique’, Journal of Clinical Medicine, 12(1), pp. 79. View online.
Yamamoto K., Sofuni A., Mukai S., Matsunami Y., Kojima H., Hirakawa N., Itoi T. 2022. ‘Use of a novel self-assembling hemostatic gel as a complementary therapeutic tool for endoscopic sphincterotomy-related bleeding’, J Hepatobiliary Pancreat Sci. 29(9), pp. e81-e83. View online.
Branchi, F., Klingenberg-Noftz, R., Friedrich, K. et al. 2021. PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study. Surg Endosc. View study online
Gagliardi, M., Sica, M., Oliviero, G., Maurano, A. and Zulli, C. 2021. “Endoscopic Application of PuraStat^® in the Treatment of Solitary Rectal Ulcer Syndrome”, Journal of Gastrointestinal and Liver Diseases. View study online
Arndtz S, Subramaniam S, Hossain E, Abdelrahim M, Ang Y, Beintaris I, di Pietro M, Iacucci M, Saunders B, Suzuki N, Bhandari P. 2020. Outcomes from the UK PuraStat Registry- A Multicentre Prospective Observational Study to Evaluate the Role of PuraStat in the Management of Gastrointestinal Bleeding (POPS). [Abstract presentation (virtual) ESGE Days Congress 23rd-25th April 2020] Endoscopy. 52: S1–S350 View more info
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. and Manes, G., 2020. Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding. Endoscopy. View study online
Ortenzi, M. and Haji, A., 2020. Safety and feasibility of PuraStat^® in laparoscopic colorectal surgery (Feasibility study). Minimally Invasive Therapy & Allied Technologies, pp.1-6. View study online
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. ‘A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial.' Endoscopy. Online ahead of print. (1):155‐162. PMID: 32679602. View study online
Negreanu, L., Chirculescu, F. and Goran, L. 2019. “Endoscopic Hemostasis of a Pleural Hemorrhage using a Hemostatic Gel”, Journal of Gastrointestinal and Liver Diseases, 28(2), pp. 148-148. View study online
Subramaniam, S., Kandiah, K., Thayalasekaran, S., Longcroft-Wheaton, G. and Bhandari, P., 2019. Haemostasis and prevention of bleeding related to ER: The role of a novel self-assembling peptide. United European Gastroenterology Journal, 7(1), pp.155-162. View study online
Yoshida M., Goto N., Kawaguchi M., Koyama H., Kuroda J., Kitahora T., Iwasaki H., Suzuki S., Kataoka M., Takashi F., Kitajima M. 2014. ‘Initial clinical trial of a novel haemostat, TDM-621, in the endoscopic treatments of the gastric tumors’, J Gastroenterol Hepatol. 29(4), pp. 77-79. View online.

GI - ERCP

Studies related to PuraStat usage for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Inoue T., Ibusuki M., Kitano R., Kobayashi Y., Ito K., Yoneda M. 2023. ‘Successful hemostasis using a self-assembling peptide hydrogel for bleeding after endoscopic papillary large-balloon dilation’, Endoscopy, 55(Suppl 1), pp. E555-E556. View online.
Lesmana C.R.A., Sandra S., Paramitha M.S., Gani R.A., Lesmana L.A. 2023. ‘Endoscopic Management Using Novel Haemostatic Agents for Immediate Bleeding during Endoscopic Retrograde Cholangio-Pancreatography’, Canadian Journal of Gastroenterology and Hepatology. 5212580. View online.

GI - Haemorrhagic RP

Studies related to procedures for treating haemorrhagic radiation proctopathy (RP)

White K. and Henson, C. 2019. PWE-048 Endoscopically-delivered PuraStat^® for the treatment of severe haemorrhagic radiation proctopathy: A case series. Gut, 68, A195-A196. View study online
White K, Henson C. 2021. Endoscopically delivered PuraStat^® for the treatment of severe haemorrhagic radiation proctopathy: a service evaluation of a new endoscopic treatment for a challenging condition, Frontline Gastroenterology. View study online

GI - Delayed Bleeding

Studies related to GI Endoscopy and Laparoscopy: Reduction of delayed bleeding (DB) after GI ESD in the colon

Gopakumar H., Vohra I., Sharma N., Puli S.R. 2023. ‘Efficacy of self-assembling peptide in mitigating delayed bleeding after advanced endoscopic resection of gastrointestinal lesions. A meta-analysis.’ Endoscopy International Open. View online.
Kubo K., Hayasaka S., Kitaguchi Tanaka I. 2022. ‘Delayed bleeding after precut sphincterotomy successfully treated with a novel self-assembling peptide gel’, Gastrointest. Endosc., 97(2), pp. 374-376. View online.
Arndtz S, Subramaniam S, Hossain E, Abdelrahim M, Ang Y, Beintaris I, di Pietro M, Iacucci M, Saunders B, Suzuki N, Bhandari P. 2020. Outcomes from the UK PuraStat Registry- A Multicentre Prospective Observational Study to Evaluate the Role of PuraStat^® in the Management of Gastrointestinal Bleeding (POPS). [Abstract presentation (virtual) ESGE Days Congress 23rd-25th April 2020] Endoscopy. 52: S1–S350.
Soons, E, Turan. A, van Geenen. E, Peter Siersema. P. 2020. ‘Application of a novel self‑assembling peptide to prevent hemorrhage after EMR, a feasibility and safety study.' Surgical Endoscopy. Online ahead of print. PMID: 32804267 View study online
Subramaniam, S., Kandiah, K., Thayalasekaran, S., Longcroft-Wheaton, G. and Bhandari, P., 2018. Bleeding during Endoscopic Submucosal Dissection: A Randomised Controlled Trial of a Novel Haemostatic Agent. United European Gastroenterology Journal, 6. View study online
Subramaniam, S., Kandiah, K., Fujimoto, A., Yahagi, N., Uraoka, T. and Bhandari, P., 2017. Minimising the risk of delayed bleeding in colonic endoscopic submucosal dissection: Is there a role for a novel haemostatic peptide?. United European Gastroenterology Journal, 5, pp.A1-A160. View study online
Pioche, M., Camus, M., Rivory, J., Leblanc, S., Lienhart, I., Barret, M., Chaussade, S., Saurin, J., Prat, F. and Ponchon, T., 2016. A self-assembling matrix-forming gel can be easily and safely applied to prevent delayed bleeding after endoscopic resections. Endoscopy International Open, 04(04), pp.E415-E419. View study online

Cardiac and Vascular

Studies related to Cardiac and Vascular Surgery

Stenson KM, Loftus IM, Chetter I, Fourneau I, Cavanagh S, Bicknell C, Loftus P. 2022. ‘A Multi-Centre, Single-Arm Clinical Study to Confirm Safety and Performance of PuraStat®, for the Management of Bleeding in Elective Carotid Artery Surgery.’ Clin Appl Thromb Hemost. Jan-Dec;28:10760296221144307. View online.
Morshuis, M., Schönbrodt, M. and Gummert, J., 2019. 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. The Journal of Heart and Lung Transplantation, 38(4), p.S194. View study online
Giritharan, S., Salhiyyah, K., Tsang, G. and Ohri, S., 2018. Feasibility of a novel, synthetic, self-assembling peptide for suture-line haemostasis in cardiac surgery. Journal of Cardiothoracic Surgery, 13(1). View study online
Masuhara, H., Fujii, T., Watanabe, Y., Koyama, N. and Tokuhiro, K., 2012. Novel Infectious Agent-Free Hemostatic Material (TDM-621) in Cardiovascular Surgery. Annals of Thoracic and Cardiovascular Surgery, 18(5), pp.444-451. View study online

Ear Nose and Throat

Studies related to ENT Surgery

Michaels J., Patel N., Kaleva A., Bateman L., Wakelam O., Stephens J. 2023. ‘Intra-Operative PuraBond Haemostats: A Comparative Trial in Adult Tonsillectomy’ Poster presented at BACO, The British Academic Conference of Otolaryngology, February 14-17. View poster
Sahota B., Khan M., Jeong B., Takhar A., Hodge J.C., Krishnan S., Foreman A. 2023. ‘Comparison between PuraStat and SurgiFlo as haemostatic agents used in oncologic Transoral Robotic Surgery (TORS)’ Poster presented at BACO, The British Academic Conference of Otolaryngology, February 14-17. View poster
Friedland Y., Bagot d’Arc M., Delin C., Ha J. (2022) 'The Use of Self-Assembling Peptides (PuraStat™) in Functional Endoscopic Sinus Surgery for Haemostasis and Reducing Adhesion Formation. A Case Series of 94 Patients' Surgical Technology International, 41. View online
Gangner Y, Bagot d’Arc M, Delin C (2022) ‘The use of self-assembling peptides (PuraStat) for hemostasis in cervical endocrine surgery. A real-life case series of 353 patients.’ International Journal of Surgery Case Reports, 94. View online
Gupta K.K., Garas G., Idle M., Germain S., De M. 2022. ‘Evaluating the role of the self-assembling topical haemostat PuraBond in Transoral Robotic Surgery (TORS) for oropharyngeal cancer: A case series’ Annals of Medicine and Surgery, 80. View online.
Soodin D., Chong S., Morrissey D., Ha J., Naidoo Y., Foreman A., Switajewski M., Robinson D., Sprague A., Bagot D’Arc M. 2022. ‘RADA16, a Self-Assembling Peptide (SAP) for Haemostasis in Nasal Endoscopic Surgery, a Case Series in Australia’, Surgery & Case Studies: Open Access Journal. View online.
Wong E, Ho J, Smith M, Sritharan N, Riffat F, Smith MC. 2020. ‘Use of PuraStat, a novel haemostatic matrix based on self-assembling peptides in the prevention of nasopharyngeal adhesion formation’ Int J Surg Case Rep. 70: 227–229. View study online
Lee, M., Ma, Z. and Ananda, A. 2017. A novel haemostatic agent based on self-assembling peptides in the setting of nasal endoscopic surgery, a case series. International Journal of Surgery Case Reports, 41, pp.461-464. View study online

Additional Clinical Areas

Liver Surgery

Christopher B. Nahm, Irinel Popescu, Florin Botea, Stephen Fenwick, Constantine Fondevila, Itxarone Bilbao, Daniel Reim & Giles J. Toogood. 2021. ‘A multi-center postmarket clinical study to confirm safety and performance of PuraStat^® in the management of bleeding during open liver resection’. HPB. View study online

Robotics

Stefan S, Wagh M, Siddiqi N, Naqvi S, Rawlinson E, Shepherd A, Khan J. 2021. ‘Self-assembling peptide haemostatic gel reduces incidence of pelvic collection after total mesorectal excision: Prospective cohort study’. Annals of Medicine and Surgery. v68:102553. View study online

Pre-Clinical Studies

Gil E.S, Aleksi E., Spirio L. 2021. ‘PuraStat^® RADA16 Self-Assembling Peptide Reduces Postoperative Abdominal Adhesion Formation in a Rabbit Cecal Sidewall Injury Model’. Front Bioeng Biotechnol. 9:782224. View study online
Gil E.S, et al. Comparison of PuraStat selfassembling peptide hydrogel versus mineral-based Hemospray for endoscopic hemostasis of upper and lower gastrointestinal lesions in pigs. Front. Gastroenterol. 2022; 1:971353. doi: 10.3389/fgstr.2022.971353. View study online.

Peptide Technology and RADA16

Sankar S. et al. 2021. ‘Clinical Use of the Self-Assembling Peptide RADA16: A Review of Current and Future Trends in Biomedicine’. Front Bioeng Biotechnol. View study online

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: infoeu@puramatrix.com

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