PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

Obesity Clinical Trial

Official title:

PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02254395
• Other study ID #: PINS-010
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 29, 2014
• Last updated: October 13, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: 010-59361265
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Deep Brain Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Body weight will be recorded at every follow-up visit.	12 month	Yes
Secondary	Body Mass Index (BMI)		12 month	Yes
Secondary	Food Intake		12 month	Yes