Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
Study NCT ID:
NCT04348266
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2020-04-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RFA for GIM Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The endoscopist who do the final endoscopy for assessing the efficacy of RFA will be blinded to the previous assigned location of RFA treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-29', 'studyFirstSubmitDate': '2020-04-12', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of GIM lesions regression', 'timeFrame': '1 year', 'description': 'Regression of GIM lesions after RFA treatment compared to no treatment'}], 'secondaryOutcomes': [{'measure': 'Number of GIM regression by location', 'timeFrame': '1 year', 'description': 'Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Intestinal Metaplasia', 'Treatment', 'Radio-frequency Ablation']}, 'descriptionModule': {'briefSummary': 'Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.', 'detailedDescription': "Gastric intestinal metaplasia (GIM) is a pre-malignant lesion. Currently, there is no standard treatment for this condition, thus the patients with GIM need surveillance endoscopy every 1-3 years, regarding to the severity and extension of lesion. However, the protocol for GIM surveillance is uncertain and need high cost.\n\nRadiofrequency ablation (RFA) is used for Barrett's esophagus (BE; pre-malignant lesion of esophageal adenoCA) treatment as a standard treatment. The investigators hypothesized that RFA may effective in GIM treatment.\n\nThe investigators will random GIM participants to have the RFA treatment only one site of the stomach (left or right). At the first session, the investigators will biopsy at suspected GIM lesions to confirm the diagnosis and severity of GIM. Two months later, The investigators will apply RFA to all GIM lesions at the assigned location and then every 2 months for 3 sessions or until no GIM lesion seen by endoscopy. The final endoscopy will be done at 1 year follow-up and biopsy will be performed to assess the efficacy of RFA compare to no treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18 years of age\n* Previous diagnose of extensive or incomplete GIM\n\nExclusion Criteria:\n\n* No GIM at first endoscopy\n* Previous gastric surgery\n* Coagulopathy\n* Pregnancy or lactation\n* Unable to perform appropriate peri-procedural cessation of antiplatelet/antithrombotic therapy\n* Unable to sign the consent'}, 'identificationModule': {'nctId': 'NCT04348266', 'briefTitle': 'RFA for GIM Treatment', 'organization': {'class': 'OTHER', 'fullName': 'King Chulalongkorn Memorial Hospital'}, 'officialTitle': 'Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study', 'orgStudyIdInfo': {'id': 'RP020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFA', 'description': 'The assigned location will be treated with RFA at all lesion.', 'interventionNames': ['Device: Radiofrequency ablation (RFA)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No treatment will not be performed at this location. However, if endoscopist detects any suspicious lesion during the scheduled endoscopy, the biopsy will be done and standard treatment will be performed accordingly.'}], 'interventions': [{'name': 'Radiofrequency ablation (RFA)', 'type': 'DEVICE', 'description': "Radiofrequency ablation is a device that can generate the heat from radiofrequency for tissue ablation. RFA is a standard treatment for Barrett' esophagus and high grade dysplasia in esophagus.", 'armGroupLabels': ['RFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Rapat Pittayanon', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Do not share IPD to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Chulalongkorn Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Rapat Pittayanon', 'investigatorAffiliation': 'King Chulalongkorn Memorial Hospital'}}}}