PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02254395

Enrollment

Registered

2014-10-01

Start date

2016-12-31

Completion date

2018-12-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

DEVICEDeep Brain Stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Body Weight	12 month	Body weight will be recorded at every follow-up visit.

Secondary

Measure	Time frame
Body Mass Index (BMI)	12 month
Food Intake	12 month

Contacts

Primary ContactJia Fumin, PhD

pins_medical@163.com010-59361265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026