Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254395
Recruitment Status : Unknown
Verified August 2016 by Beijing Pins Medical Co., Ltd.
Recruitment status was:  Not yet recruiting
First Posted : October 1, 2014
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

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 patients with obesity.

Condition or disease Intervention/treatment Phase
Obesity Device: Deep Brain Stimulation Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Deep Brain Stimulation
Stimulation is on.
Device: Deep Brain Stimulation
Other Name: PINS Stimulator System

Sham Comparator: Placebo
Sham Stimulation: Stimulation is off.
Device: Deep Brain Stimulation
Other Name: PINS Stimulator System




Primary Outcome Measures :
  1. Body Weight [ Time Frame: 12 month ]
    Body weight will be recorded at every follow-up visit.


Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: 12 month ]
  2. Food Intake [ Time Frame: 12 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is aged 18 to 65.
  2. Body Mass Index [BMI] >40 kg/m2.

Exclusion Criteria:

  1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery
  2. 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.
  3. Participate in other clinical trial;
  4. Has a life expectancy of < 1 year.
  5. The investigator and/or enrollment review committee, would preclude participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254395


Contacts
Layout table for location contacts
Contact: Jia Fumin, PhD 010-59361265 pins_medical@163.com

Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital
Investigators
Layout table for investigator information
Study Chair: Li Luming, PhD Tsinghua University
Layout table for additonal information
Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02254395    
Other Study ID Numbers: PINS-010
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight