Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-05 @ 3:46 AM
Study NCT ID:
NCT01614418
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2012-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological clearance of dysplasia/metaplasia', 'timeFrame': '6 month'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'up to 6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Dysplasia', 'Intestinal Metaplasia']}, 'referencesModule': {'references': [{'pmid': '26897966', 'type': 'DERIVED', 'citation': 'Leung WK, Tong DK, Leung SY, Chan FS, Tong TS, Ho RS, Chu KM, Law SY. Treatment of Gastric Metaplasia or Dysplasia by Endoscopic Radiofrequency Ablation: A Pilot Study. Hepatogastroenterology. 2015 May;62(139):748-51.'}]}, 'descriptionModule': {'briefSummary': "Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions.\n\nEndoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological confirmation of gastric IM or dysplasia.\n2. The lesion is no larger than 5 cm in diameter.\n3. Age ≥ 18 years.\n4. No previous endoscopic mucosal resection or submucosal dissection.\n5. No active H. pylori infection.\n6. Subject is able to tolerate endoscopy and sedation.\n7. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Gastric cancer (intra-mucosal cancer or worse).\n2. Prior gastric irradiation or surgery.\n3. Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA.\n4. Gastric ulcers, fistulae and varices.\n5. History of alcohol and/or controlled substance dependency.\n6. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT01614418', 'briefTitle': 'Radiofrequency Ablation for Gastric Metaplasia and Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia', 'orgStudyIdInfo': {'id': 'HKU_WKL_RFA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscopic radiofrequency ablation', 'description': 'Endoscopic radiofrequency ablation using BARRX HALO90 catheter', 'interventionNames': ['Device: Endoscopic radiofrequency ablation catheter']}], 'interventions': [{'name': 'Endoscopic radiofrequency ablation catheter', 'type': 'DEVICE', 'otherNames': ['BARRX HALO90'], 'description': 'Endoscopic radiofrequency ablation', 'armGroupLabels': ['Endoscopic radiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Wai Keung Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'LEUNG Wai Keung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}