PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

NCT ID: NCT02254395

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Deep Brain Stimulation

Stimulation is on.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Placebo

Sham Stimulation: Stimulation is off.

Group Type SHAM_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

Interventions

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Deep Brain Stimulation

Intervention Type DEVICE

Other Intervention Names

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PINS Stimulator System

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Luming, PhD

Role: STUDY_CHAIR

Tsinghua University

Central Contacts

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Jia Fumin, PhD

Role: CONTACT

010-59361265

Other Identifiers

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PINS-010

Identifier Type: -

Identifier Source: org_study_id

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