Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

CompletedOBSERVATIONAL
Enrollment

41

Participants

Timeline

Start Date

September 19, 2022

Primary Completion Date

January 23, 2025

Study Completion Date

January 23, 2025

Conditions
Esophageal StrictureStricture
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.

Trial Locations (6)

10032

Columbia University Irving Medical Center, New York

21205

Johns Hopkins, Baltimore

32803

AdventHealth Orlando, Orlando

46845

Parkview, Fort Wayne

77505

Baylor St. Lukes, Houston

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AdventHealth

OTHER