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.

Select a clinical area:

Acute GI BleedsERCPRadiation ProctopathyResection (Intraprocedural & Delayed Bleeds)Pancreatic Necrosectomy

ColorectalGynaeLiver

ProstatectomyPartial Nephrectomy

Ear, Nose & ThroatHead & NeckPlastic Surgery

Cardiac

All

RADA16 Studies

 

GI – Acute Bleeds

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]

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]

[View more]

 

ERCP

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]

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 & Delayed Bleeding)

2024

• ‘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]

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]

[View more]

 

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]

 

General Surgery

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]

Gynae

• ‘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]

• ‘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]

 

Urology

Prostatectomy

• ‘A thermal nerve sparing robot-assisted radical prostatectomy: initial experience with microporous polysaccharide hemospheres as a topical hemostatic agent’

  Nunez-Nateras R., Hurd K.J., Ferrigni E.N. et al. 2023. World J Urol 31, 523–527. [Read]

Partial Nephrectomy

• ‘Comparison between Tisseel an 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]

 

Ear, Nose & Throat

2023

• ‘Intra-Operative PuraBond Haemostats: A Comparative Trial in Adult Tonsillectomy’

  Michaels J., Patel N., Kaleva A., Bateman L., Wakelam O., Stephens J. Poster presented at BACO, The British Academic Conference of Otolaryngology, February 14-17. [Read]

• ‘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]

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]

 

Plastic Surgery

2023

• ‘Facelift Patients Receiving Intraoperative Administration of a Self-assembling Hemostat Agent Experienced Minimal Bruising and No Acute Hematomas: A Pilot Study’

  Few J. 2022. Aesthetic Surgery Journal Open Forum, 2022 [Read]

 

Cardiac Surgery

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.’

  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]

2020 and earlier

• ‘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 Studies

• ‘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]

 

Peptide Technology and RADA16

• ‘Clinical Use of the Self-Assembling Peptide RADA16: A Review of Current and Future Trends in Biomedicine’

  Sankar S. et al. 2021. Front Bioeng Biotechnol. [Read]

• ‘Discovery and Design of Self-Assembling Peptides’

  Zhang S. 2017. InterfaceFocus7:20170028. [Read]

 

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