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PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

Primary Purpose

Obesity

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Deep Brain Stimulation

    Placebo

    Arm Description

    Stimulation is on.

    Sham Stimulation: Stimulation is off.

    Outcomes

    Primary Outcome Measures

    Body Weight
    Body weight will be recorded at every follow-up visit.

    Secondary Outcome Measures

    Body Mass Index (BMI)
    Food Intake

    Full Information

    First Posted
    September 29, 2014
    Last Updated
    October 13, 2016
    Sponsor
    Beijing Pins Medical Co., Ltd
    Collaborators
    Beijing Tiantan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02254395
    Brief Title
    PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
    Official Title
    PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Pins Medical Co., Ltd
    Collaborators
    Beijing Tiantan Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Deep Brain Stimulation
    Arm Type
    Experimental
    Arm Description
    Stimulation is on.
    Arm Title
    Placebo
    Arm Type
    Sham Comparator
    Arm Description
    Sham Stimulation: Stimulation is off.
    Intervention Type
    Device
    Intervention Name(s)
    Deep Brain Stimulation
    Other Intervention Name(s)
    PINS Stimulator System
    Primary Outcome Measure Information:
    Title
    Body Weight
    Description
    Body weight will be recorded at every follow-up visit.
    Time Frame
    12 month
    Secondary Outcome Measure Information:
    Title
    Body Mass Index (BMI)
    Time Frame
    12 month
    Title
    Food Intake
    Time Frame
    12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jia Fumin, PhD
    Phone
    010-59361265
    Email
    pins_medical@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li Luming, PhD
    Organizational Affiliation
    Tsinghua University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

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