Status:
UNKNOWN
PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
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 patie...
Eligibility Criteria
Inclusion
- Subject is aged 18 to 65.
- Body Mass Index \[BMI\] \>40 kg/m2.
Exclusion
- Medical contraindications for general anesthesia, craniotomy, or DBS surgery
- 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.
- Participate in other clinical trial;
- Has a life expectancy of \< 1 year.
- The investigator and/or enrollment review committee, would preclude participation in the study.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02254395
Start Date
December 1 2016
End Date
December 1 2018
Last Update
October 14 2016
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