Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

Last updated: January 23, 2025
Sponsor: AdventHealth
Overall Status: Completed

Phase

N/A

Condition

Esophageal Disorders

Achalasia

Treatment

Purastat SAP gel application

Clinical Study ID

NCT05581173
1931151
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older

  • Patients at high-risk for esophageal stricture formation defined as undergoingendoscopic resection in the esophagus involving more than 50% of the circumference

Exclusion

Exclusion Criteria:

  • Any standard contraindication to anesthesia and/or endoscopy

  • Participation in another research protocol that could interfere or influence theoutcomes measures of the present study.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Purastat SAP gel application
Phase:
Study Start date:
September 19, 2022
Estimated Completion Date:
January 23, 2025

Study Description

In recent years, endoscopic resection by endoscopic mucosal resection(EMR) or endoscopic submucosal dissection(ESD) has become standard practice for the removal of superficial neoplasia (precancerous lesions and early cancer) throughout the gastrointestinal tract. These procedures are associated with lower morbidity and mortality when compared to conventional surgery.

Nonetheless, stricture formation following endoscopic resection of gastrointestinal lesions is a well-known risk, particularly in the esophagus. The main risk factor for esophageal stricture formation following EMR/ESD is resection size, with this increasing with the length and extent of the circumferential excision, reaching 100% stricture formation when the entire circumference is involved. Stricture formation is associated with significant morbidity and increasing health care utilization, as multiple endoscopies are often required as part of the management of these difficult to treat strictures.

Recently, a self-assembling peptide (SAP) forming gel (Purastat; 3D Matrix, Ltd, Tokyo, Japan) has been approved by the Food and Drug Administration (FDA) as an agent that that promotes healing, which may potentially reduce the risk of stricture formation. Initial small studies from Europe appear to show benefit but the magnitude of the effect has not been well defined. Furthermore, large prospective US based studies are currently lacking. Therefore, the aim of this study is to assess the efficacy of this novel SAP gel in the prevention of stricture formation after endoscopic resection in high-risk patients as utilized as part of clinically indicated standard patient care.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Site Not Available

  • Parkview

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Baylor St. Lukes

    Houston, Texas 77505
    United States

    Site Not Available

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