NCT02254395

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for early_phase_1 obesity

Timeline
Completed

Started Dec 2016

Typical duration for early_phase_1 obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 14, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

September 29, 2014

Last Update Submit

October 13, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body Weight

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

    12 month

Secondary Outcomes (2)

  • Body Mass Index (BMI)

    12 month

  • Food Intake

    12 month

Study Arms (2)

Deep Brain Stimulation

EXPERIMENTAL

Stimulation is on.

Device: Deep Brain Stimulation

Placebo

SHAM COMPARATOR

Sham Stimulation: Stimulation is off.

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE
Also known as: PINS Stimulator System
Deep Brain StimulationPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Li Luming, PhD

    Tsinghua University

    STUDY CHAIR

Central Study Contacts

Jia Fumin, PhD

CONTACT

010-59361265pins_medical@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 14, 2016

Record last verified: 2016-08