Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-05 @ 12:22 AM
Study NCT ID:
NCT02564627
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2015-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2015-09-25', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appetite will be quantified with a visual analogic scale', 'timeFrame': '12 weeks', 'description': 'Appetite will be quantified weekly during the 12 weeks of treatment. Appetite will be quantified with a visual analogic scale (0= absence of appetite, 10=uncontrollable appetite)'}], 'secondaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '12 weeks', 'description': 'Appetite will be quantified weekly during the 12 weeks of treatment'}, {'measure': 'Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist', 'timeFrame': '12 weeks', 'description': 'The compliance with the 3 arms of treatment will be investigated. Diet complience will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Weight Loss']}, 'referencesModule': {'references': [{'pmid': '27289457', 'type': 'DERIVED', 'citation': 'Abdel-Kadar M. Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 with an Ambulatory Self-applied Patch vs PENS of Dermatome T6 with Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients. Obes Surg. 2016 Dec;26(12):2899-2905. doi: 10.1007/s11695-016-2214-0.'}]}, 'descriptionModule': {'briefSummary': 'A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups:\n\n* PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet\n* PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet\n* Only 1200Kcal/day diet\n\nThe effect on appetite and weight loss will be investigated.', 'detailedDescription': 'A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups:\n\n* PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet\n* PENS of dermatome T6 with conventional procedure (weekly stimulation in the Outpatient Clinic) + 1200Kcal/day diet\n* Only 1200Kcal/day diet\n\nThe effect on appetite and weight loss will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderately obese patients (BMI 30-39 kg/m2)\n\nExclusion Criteria:\n\n* Endocrinological diseases causing obesity\n* Heart pacemaker\n* Previous bariatric procedure'}, 'identificationModule': {'nctId': 'NCT02564627', 'briefTitle': 'PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Abdel Kadar Clinic'}, 'officialTitle': 'Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 With an Ambulatory Self-applied Patch vs PENS of Dermatome T6 With Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients', 'orgStudyIdInfo': {'id': 'KC15-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-applied patch', 'description': 'The patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed.', 'interventionNames': ['Procedure: Self-applied patch', 'Dietary Supplement: 1200 Kcal/day diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional procedure', 'description': 'The patient will attend weekly the Outpatient Clinic for receiving the PENS of dermatome T6. The procedure will be performed by the Medicine Doctor. A 1200 Kcal/day diet will be also prescribed.', 'interventionNames': ['Procedure: Conventional procedure', 'Dietary Supplement: 1200 Kcal/day diet']}, {'type': 'OTHER', 'label': '1200 Kcal/day diet', 'description': 'A 1200 Kcal/day diet will be also prescribed.', 'interventionNames': ['Dietary Supplement: 1200 Kcal/day diet']}], 'interventions': [{'name': 'Self-applied patch', 'type': 'PROCEDURE', 'description': 'An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.', 'armGroupLabels': ['Self-applied patch']}, {'name': 'Conventional procedure', 'type': 'PROCEDURE', 'description': 'PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.', 'armGroupLabels': ['Conventional procedure']}, {'name': '1200 Kcal/day diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A 1200 Kcal/day diet will be prescribed.', 'armGroupLabels': ['1200 Kcal/day diet', 'Conventional procedure', 'Self-applied patch']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mohammed Abdel Kadar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kadar Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abdel Kadar Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}