Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-28 @ 10:35 PM
Study NCT ID:
NCT06370169
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The outcome will measure number of patient had achieved complete obliteration of varices', 'timeFrame': '6 months for observation', 'description': 'Repeat Endoscopic ultrasound findings of residual flow'}], 'secondaryOutcomes': [{'measure': 'Number of patient needed re intervention', 'timeFrame': '6 months for observation', 'description': 'Repeat coil application on follow-up'}, {'measure': 'Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days)', 'timeFrame': '90 days', 'description': 'These are the definite data which will be statistically analyzed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Varices Bleeding']}, 'descriptionModule': {'briefSummary': 'The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist.', 'detailedDescription': 'In this study Principal investigator recruiting patients with high-risk gastric varices for primary prophylaxis. Gastric varices are dilated submucosal veins in the lining of the stomach, found in patients with portal hypertension or elevated pressure in the portal venous system. The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist. After the procedure patients will be discharged to home unless there is any indication for admission, such as significant abdominal pain, bleeding or chest pain. For enrolment into the study, patient has to sign an informed consent form which is provided at the end. First, we will do baseline evaluation of the patient which includes detailed clinical examination, routine laboratory tests, Upper GI Endoscopy, triphasic CT abdomen. The duration of study is 6 months. Only the routine tests necessary for the management of disease will be charged.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: -\n\nEach patient must meet all the following criteria to be enrolled in this study:\n\n1. Gastric fundal varices larger than 2.0 cm in total diameter\n2. High risk GV (GOV 2/IGV 1)\n3. Primary prophylaxis\n4. Patients with known fundal varices\n5. Ability to give a signed informed consent\n\nExclusion criteria: -\n\nThe exclusion criteria for these volunteers will be:\n\n1. Patients with a history of TIPS or any other portosystemic shunt procedure\n2. Oesophageal stricture\n3. Patient not fit for general anaesthesia\n4. Secondary prophylaxis\n5. Pediatric Patients (\\<18 years)\n6. Pregnant or lactating mother\n7. Not willing to participate'}, 'identificationModule': {'nctId': 'NCT06370169', 'acronym': 'EUS', 'briefTitle': 'EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices', 'organization': {'class': 'OTHER', 'fullName': 'Asian Institute of Gastroenterology, India'}, 'officialTitle': 'Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices', 'orgStudyIdInfo': {'id': 'ROSC 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Endoscopic ultrasound Placement of coil and glue', 'description': 'Single arm study The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue\n\nDuration 1,3,06 months for observation of gastric varices bleeding...', 'interventionNames': ['Device: Endoscopic ultrasound placement of Coil and glue']}], 'interventions': [{'name': 'Endoscopic ultrasound placement of Coil and glue', 'type': 'DEVICE', 'otherNames': ['Ultrasound'], 'description': 'The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue', 'armGroupLabels': ['Endoscopic ultrasound Placement of coil and glue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Jahangeer Dr Basha, MD DM', 'role': 'CONTACT', 'email': 'drjahangeer09@gmail.com', 'phone': '04023378888'}, {'name': 'Sandeep Dr Nath, MD', 'role': 'CONTACT', 'email': 'sandip.nath@ymail.com', 'phone': '04023378888'}], 'facility': 'Asian institute of Gastroenterology', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'centralContacts': [{'name': 'Jahangeer Dr Basha, MD DM', 'role': 'CONTACT', 'email': 'drjahangeer09@gmail.com', 'phone': '04023378888', 'phoneExt': '231'}, {'name': 'Sandeep Dr Nath, MD', 'role': 'CONTACT', 'email': 'sandip.nath@ymail.com', 'phone': '04023378888', 'phoneExt': '121'}], 'overallOfficials': [{'name': 'Mohan Dr Ramchandani, MD DM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asian Institute of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asian Institute of Gastroenterology, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Mohan Ramchandani', 'investigatorAffiliation': 'Asian Institute of Gastroenterology, India'}}}}