Status:
RECRUITING
REVerse Intestinal Metaplasia in the Stomach (REVISE)
Lead Sponsor:
Katherine Garman
Conditions:
Gastric Intestinal Metaplasia
Gastric Precancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. Response will be determined by a...
Detailed Description
The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium, an FDA-approved drug no longer in active use. The st...
Eligibility Criteria
Inclusion
- Adults (including men, women, and non-binary individuals) over age 18 with known GIM with at least one high-risk feature (extensive vs limited, incomplete or mixed-type GIM, family history of stomach cancer),
- Ability to provide informed consent,
- Evidence of prior but not active H. pylori infection
Exclusion
- Active gastric cancer diagnosis,
- High-risk of bleeding complications due to anticoagulants or underlying medical condition,
- Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06590454
Start Date
December 1 2025
End Date
October 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
Duke Health
Durham, North Carolina, United States, 27710