- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02254395
PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
October 13, 2016 updated by: Beijing Pins Medical Co., Ltd
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
8
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jia Fumin, PhD
- Phone Number: 010-59361265
- Email: pins_medical@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is aged 18 to 65.
- Body Mass Index [BMI] >40 kg/m2.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep Brain Stimulation
Stimulation is on.
|
Other Names:
|
Sham Comparator: Placebo
Sham Stimulation: Stimulation is off.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: 12 month
|
Body weight will be recorded at every follow-up visit.
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Mass Index (BMI)
Time Frame: 12 month
|
12 month
|
Food Intake
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
September 29, 2014
First Submitted That Met QC Criteria
September 29, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Estimate)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PINS-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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