Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 11:50 PM
Study NCT ID:
NCT04431232
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2020-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endo-Band: Endoscopic Band Ligation for Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '3 months', 'description': 'BMI Change'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'BMI'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23808945', 'type': 'BACKGROUND', 'citation': 'Keohane J, Berro W, Harewood GC, Murray FE, Patchett SE. Band ligation of gastric antral vascular ectasia is a safe and effective endoscopic treatment. Dig Endosc. 2013 Jul;25(4):392-6. doi: 10.1111/j.1443-1661.2012.01410.x. Epub 2012 Dec 17.'}, {'pmid': '32001332', 'type': 'BACKGROUND', 'citation': 'Jirapinyo P, Thompson CC. Endoscopic gastric body plication for the treatment of obesity: technical success and safety of a novel technique (with video). Gastrointest Endosc. 2020 Jun;91(6):1388-1394. doi: 10.1016/j.gie.2020.01.030. Epub 2020 Jan 28.'}, {'pmid': '30627991', 'type': 'BACKGROUND', 'citation': 'Abeid M, Miller KA, Kaddah T, Zaitoun N. Outcome of Primary Obesity Surgery Endolumenal Procedure as Obesity Treatment in Private Practice Setting: an Intervention Study. Obes Surg. 2019 Apr;29(4):1364-1366. doi: 10.1007/s11695-018-03698-z. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To the best of our knowledge, this is the first study to use endoscopic band ligation for weight loss. All ligatures will be performed in the gastric body starting at the distal body; 5 parallel rows, with the last one in the proximal body.The entire procedure can be completed in 30 min. Oxygen is used for endoscopic air insufflation.Endoscopy is performed using propofol for sedation.', 'detailedDescription': 'The idea of band ligation of the gastric body is to induce multiple gastric ulcers that forms a fibrotic scars which can lead to marginal narrowing of the lumen; same as that occurred in the esophagus following band ligation of esophageal varices or in the antrum following band ligation of GAVE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI \\> 27\n\nExclusion Criteria:\n\n* Any contraindication for endoscopy\n* Any gastric bleeding lesions\n* Uncontrolled use of anticoagulants or NSAID's"}, 'identificationModule': {'nctId': 'NCT04431232', 'briefTitle': 'Endo-Band: Endoscopic Band Ligation for Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'El Katib Hospital'}, 'officialTitle': 'Endoscopic Band Ligation for Weight Loss', 'orgStudyIdInfo': {'id': 'MohamedAbeid1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Band Ligation', 'description': 'Band ligation of gastric body for weight loss', 'interventionNames': ['Device: Endoscopic Band Ligation']}], 'interventions': [{'name': 'Endoscopic Band Ligation', 'type': 'DEVICE', 'description': 'Band ligation of the gastric body for weight loss', 'armGroupLabels': ['Band Ligation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Giza', 'state': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Abeid, MD', 'role': 'CONTACT', 'email': 'mohamedabeid@gmail.com', 'phone': '01001222254'}], 'facility': 'El Katib Hospital (Celopatra Group)', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Mohamed Abeid, MD', 'role': 'CONTACT', 'email': 'mohamedabeid@gmail.com', 'phone': '+201001222254'}], 'overallOfficials': [{'name': 'Mohamed Abeid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endoscopy Unit Faculty of Medicine Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'El Katib Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Gastroenterologist/ Bariatric Endoscopist Cairo University', 'investigatorFullName': 'Mohamed Abeid', 'investigatorAffiliation': 'El Katib Hospital'}}}}