Treatment Clinical Trial
Official title:
Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study
NCT number | NCT04348266 |
Other study ID # | RP020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | May 31, 2023 |
Verified date | July 2023 |
Source | King Chulalongkorn Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 31, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - More than 18 years of age - Previous diagnose of extensive or incomplete GIM Exclusion Criteria: - No GIM at first endoscopy - Previous gastric surgery - Coagulopathy - Pregnancy or lactation - Unable to perform appropriate peri-procedural cessation of antiplatelet/antithrombotic therapy - Unable to sign the consent |
Country | Name | City | State |
---|---|---|---|
Thailand | Rapat Pittayanon | Pathum Wan | Bangkok |
Lead Sponsor | Collaborator |
---|---|
King Chulalongkorn Memorial Hospital |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of GIM lesions regression | Regression of GIM lesions after RFA treatment compared to no treatment | 1 year | |
Secondary | Number of GIM regression by location | Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment | 1 year |
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