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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 Use1,2.


1. PuraStat IFU-007 Rev2; 2. PuraBond IFU-009 Rev2

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GI - Haemostatic Efficacy GI - Delayed Bleeding Cardiac and Vascular Ear Nose and Throat Haemorrhagic Radiation Proctopathy Additional Clinical Areas Pre-Clinical Studies Peptide Technology and RADA16
3dMatrix Company History

GI - Haemostatic Efficacy

Studies related to GI Endoscopy and Laparoscopy: Haemostatic efficacy

  • 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., 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

  • 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

  • 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

  • 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, 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

  • 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

  • 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

3dMatrix Company History

GI - Delayed Bleeding

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

  • 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

  • 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

  • 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

  • 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

  • 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.

3dMatrix Company History

Cardiac and Vascular

Studies related to Cardiac and Vascular Surgery

  • 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

  • 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

3dMatrix Company History

Ear Nose and Throat

Studies related to ENT Surgery

  • 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

  • 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

  • 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

3dMatrix Company History

Haemorrhagic Radiation Proctopathy

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

3dMatrix Company History

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

3dMatrix Company History

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

3dMatrix Company History

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!