NCT06590454 REVerse Intestinal Metaplasia in the Stomach (REVISE)
| NCT ID | NCT06590454 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Katherine Garman |
| Condition | Gastric Intestinal Metaplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2025-12-15 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 assessing the extent and quality of the gastric intestinal metaplasia before and after treatment. A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Katherine Garman, MD
PRINCIPAL INVESTIGATOR
Duke Health
Frequently Asked Questions
Who can join the NCT06590454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Intestinal Metaplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06590454 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06590454 currently recruiting?
Yes, NCT06590454 is actively recruiting participants. Contact the research team at nicole.pavlus@duke.edu for enrollment information.
Where is the NCT06590454 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06590454 clinical trial?
NCT06590454 is sponsored by Katherine Garman. The principal investigator is Katherine Garman, MD at Duke Health. The trial plans to enroll 32 participants.