Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-02-08 @ 12:26 PM
Study NCT ID:
NCT02254395
Status:
UNKNOWN
Last Update Posted:
2016-10-14
First Post:
2014-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '12 month', 'description': 'Body weight will be recorded at every follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': '12 month'}, {'measure': 'Food Intake', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is aged 18 to 65.\n2. Body Mass Index \\[BMI\\] \\>40 kg/m2.\n\nExclusion Criteria:\n\n1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery\n2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.\n3. Participate in other clinical trial;\n4. Has a life expectancy of \\< 1 year.\n5. The investigator and/or enrollment review committee, would preclude participation in the study."}, 'identificationModule': {'nctId': 'NCT02254395', 'briefTitle': 'PINS Stimulator System for Deep Brain Stimulation to Treat Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Pins Medical Co., Ltd'}, 'officialTitle': 'PINS Stimulator System for Deep Brain Stimulation to Treat Obesity', 'orgStudyIdInfo': {'id': 'PINS-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep Brain Stimulation', 'description': 'Stimulation is on.', 'interventionNames': ['Device: Deep Brain Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Sham Stimulation: Stimulation is off.', 'interventionNames': ['Device: Deep Brain Stimulation']}], 'interventions': [{'name': 'Deep Brain Stimulation', 'type': 'DEVICE', 'otherNames': ['PINS Stimulator System'], 'armGroupLabels': ['Deep Brain Stimulation', 'Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jia Fumin, PhD', 'role': 'CONTACT', 'email': 'pins_medical@163.com', 'phone': '010-59361265'}], 'overallOfficials': [{'name': 'Li Luming, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tsinghua University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Pins Medical Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}