Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

NCT05581173 | Completed

• 1 other identifier: 1931151
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 6

Brief Summary

The study is designed as a multicenter prospective registry study evaluating the efficacy of the self-assembling peptide in the prevention of stricture formation after endoscopic resection as part of standard medical care. No experimental interventions will be performed.

Conditions

Esophageal Stricture; Stricture

Outcome Measures

Primary Outcomes (1)

• Rate of stricture formation

  Esophageal stricture will be defined as symptoms of dysphagia with concomitant endoscopy showing an inability to pass a standard endoscope due to luminal narrowing at the site of the resection scar.

  12 months

Secondary Outcomes (1)

• Workability of self-assembling peptide (SAP) gel application

  12 months

Study Arms (1)

Endoscopic resection of gastrointestinal lesion(s)

Endoscopic mucosal resection or endoscopic submucosal dissection is an outpatient procedure to remove superficial neoplasia(precancerous lesions and early cancer) throughout the gastrointestinal tract.

Device: Purastat SAP gel application

Interventions

Purastat SAP gel application DEVICE

Purastat is a fully synthetic matrix scaffold that can be applied through an endoscopic catheter. Purastat is FDA approved and commercially available. Purastat is a peptide solution that self assembles at physiological potential Hydrogen(pH) and forms a gel comprising a network of nanofibers. Its benefits in hemostasis and tissue healing and its biocompatibility have been previously demonstrated in animal models and also in human cases. When the gel comes into contact with blood or tissue fluids, the change in potential hydrogen (pH) and salt concentration causes fiber formation and gelation that block the blood vessels in the hemorrhagic area to generate hemostatic effects and also prevention of scar tissue formation.

Endoscopic resection of gastrointestinal lesion(s)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients referred to the participating centers for endoscopic resection of GI lesions may be eligible for entry into the study.

You may qualify if:

• Age 18 years or older
• Patients at high-risk for esophageal stricture formation defined as undergoing endoscopic resection in the esophagus involving more than 50% of the circumference

You may not qualify if:

• Any standard contraindication to anesthesia and/or endoscopy
• Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (6)

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Parkview

Fort Wayne, Indiana, 46845, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Baylor St. Lukes

Houston, Texas, 77505, United States

Location

Related Publications (5)

• Gil ES, Aleksi E, Spirio L. PuraStat RADA16 Self-Assembling Peptide Reduces Postoperative Abdominal Adhesion Formation in a Rabbit Cecal Sidewall Injury Model. Front Bioeng Biotechnol. 2021 Dec 10;9:782224. doi: 10.3389/fbioe.2021.782224. eCollection 2021.

  PMID: 34957076 BACKGROUND

• Subramaniam S, Kandiah K, Thayalasekaran S, Longcroft-Wheaton G, Bhandari P. Haemostasis and prevention of bleeding related to ER: The role of a novel self-assembling peptide. United European Gastroenterol J. 2019 Feb;7(1):155-162. doi: 10.1177/2050640618811504. Epub 2018 Nov 5.

  PMID: 30788128 BACKGROUND

• Wong E, Ho J, Smith M, Sritharan N, Riffat F, Smith MC. Use of Purastat, a novel haemostatic matrix based on self-assembling peptides in the prevention of nasopharyngeal adhesion formation. Int J Surg Case Rep. 2020;70:227-229. doi: 10.1016/j.ijscr.2020.04.027. Epub 2020 May 8.

  PMID: 32422584 BACKGROUND

• Yu M, Tan Y, Liu D. Strategies to prevent stricture after esophageal endoscopic submucosal dissection. Ann Transl Med. 2019 Jun;7(12):271. doi: 10.21037/atm.2019.05.45.

  PMID: 31355238 BACKGROUND

• Uraoka T, Ochiai Y, Fujimoto A, Goto O, Kawahara Y, Kobayashi N, Kanai T, Matsuda S, Kitagawa Y, Yahagi N. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointest Endosc. 2016 Jun;83(6):1259-64. doi: 10.1016/j.gie.2015.11.015. Epub 2015 Dec 1.

  PMID: 26608126 BACKGROUND

MeSH Terms

Conditions

Esophageal Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis Yang, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: September 19, 2022
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)