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Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

NCT05581173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2025-01-24

No results posted yet for this study

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

Interventions

DEVICE

Purastat SAP gel application

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.

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Dennis Yang, MD · AdventHealth

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2025-01-23
Completion
2025-01-23

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581173 on ClinicalTrials.gov