Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-31 @ 9:31 PM
Study NCT ID:
NCT04931706
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nissen Sleeve by Single Port With Magnetic Assistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], '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'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Complications', 'timeFrame': '1 month', 'description': 'any adverse event during the surgery'}, {'measure': 'Surgical time', 'timeFrame': '30 minutes', 'description': 'how long does the surgery take'}, {'measure': 'Weight loss follow up', 'timeFrame': '1 month', 'description': 'Kg that the patient loss'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric Surgery', 'Magnetic assisted', 'Singe port', 'Nissen Sleeve'], 'conditions': ['Bariatric Surgery Candidate', 'Obesity', 'GERD']}, 'descriptionModule': {'briefSummary': 'New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system', 'detailedDescription': 'A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the UICBM from Venezuela-Colombia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with controlled comorbidities suffering from obesity and GERD.\n\nExclusion Criteria:\n\n* Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases'}, 'identificationModule': {'nctId': 'NCT04931706', 'briefTitle': 'Nissen Sleeve by Single Port With Magnetic Assistance', 'organization': {'class': 'OTHER', 'fullName': 'Unidad Internacional de Cirugia Bariatrica y Metabolica'}, 'officialTitle': 'Double Magnetic-assisted Single-port Nissen Sleeve', 'orgStudyIdInfo': {'id': 'UICBM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'N-Sleve patients', 'description': 'Patient that were selected for surgery', 'interventionNames': ['Other: Magnetics Assisted by Singe port']}], 'interventions': [{'name': 'Magnetics Assisted by Singe port', 'type': 'OTHER', 'description': 'Use of magnet for assistance through the surgery, and a novel approach as it is single port', 'armGroupLabels': ['N-Sleve patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4002', 'city': 'Maracaibo', 'state': 'Zulia', 'status': 'RECRUITING', 'country': 'Venezuela', 'contacts': [{'name': 'Guillermo Borjas, M.D', 'role': 'CONTACT'}], 'facility': 'Unidad Internacional de Cirugia Bariatric y Metabolica', 'geoPoint': {'lat': 10.64232, 'lon': -71.61089}}], 'centralContacts': [{'name': 'Guillermo Borjas, M.D.', 'role': 'CONTACT', 'email': 'MaldonadoAndres94@gmail.com', 'phone': '4146863041'}], 'overallOfficials': [{'name': 'Andres Maldonado, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UICBM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unidad Internacional de Cirugia Bariatrica y Metabolica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Guillermo Borjas', 'investigatorAffiliation': 'Unidad Internacional de Cirugia Bariatrica y Metabolica'}}}}