<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02254395</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-010</org_study_id>
    <nct_id>NCT02254395</nct_id>
  </id_info>
  <brief_title>PINS Stimulator System for Deep Brain Stimulation to Treat Obesity</brief_title>
  <official_title>PINS Stimulator System for Deep Brain Stimulation to Treat Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Pins Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Pins Medical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical study is to verify the long term effecacy and safety of a&#xD;
      bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a&#xD;
      treatment option for patients with obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Weight</measure>
    <time_frame>12 month</time_frame>
    <description>Body weight will be recorded at every follow-up visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Intake</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulation is on.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Stimulation: Stimulation is off.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation</intervention_name>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>PINS Stimulator System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is aged 18 to 65.&#xD;
&#xD;
          2. Body Mass Index [BMI] &gt;40 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery&#xD;
&#xD;
          2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and&#xD;
             ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or&#xD;
             subdural hematomas.&#xD;
&#xD;
          3. Participate in other clinical trial;&#xD;
&#xD;
          4. Has a life expectancy of &lt; 1 year.&#xD;
&#xD;
          5. The investigator and/or enrollment review committee, would preclude participation in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Luming, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tsinghua University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia Fumin, PhD</last_name>
    <phone>010-59361265</phone>
    <email>pins_medical@163.com</email>
  </overall_contact>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>October 13, 2016</last_update_submitted>
  <last_update_submitted_qc>October 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02254395
org study id: PINS-010
nct id: NCT02254395
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Body Weight
time frame: 12 month
description: Body weight will be recorded at every follow-up visit.
measure: Body Mass Index (BMI)
time frame: 12 month
measure: Food Intake
time frame: 12 month
arm group label: Deep Brain Stimulation
arm group type: Experimental
description: Stimulation is on.
arm group label: Placebo
arm group type: Sham Comparator
description: Sham Stimulation: Stimulation is off.
intervention type: Device
intervention name: Deep Brain Stimulation
arm group label: Deep Brain Stimulation
arm group label: Placebo
other name: PINS Stimulator System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li Luming, PhD
role: Study Chair
affiliation: Tsinghua University
last name: Jia Fumin, PhD
phone: 010-59361265
email: pins_medical@163.com
responsible party type: Sponsor
mesh term: Obesity