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PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

Primary Purpose

Weight Loss

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Self-applied patch
Conventional procedure
1200 Kcal/day diet
Sponsored by
Abdel Kadar Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderately obese patients (BMI 30-39 kg/m2)

Exclusion Criteria:

  • Endocrinological diseases causing obesity
  • Heart pacemaker
  • Previous bariatric procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Other

    Arm Label

    Self-applied patch

    Conventional procedure

    1200 Kcal/day diet

    Arm Description

    The patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed.

    The patient will attend weekly the Outpatient Clinic for receiving the PENS of dermatome T6. The procedure will be performed by the Medicine Doctor. A 1200 Kcal/day diet will be also prescribed.

    A 1200 Kcal/day diet will be also prescribed.

    Outcomes

    Primary Outcome Measures

    Appetite will be quantified with a visual analogic scale
    Appetite will be quantified weekly during the 12 weeks of treatment. Appetite will be quantified with a visual analogic scale (0= absence of appetite, 10=uncontrollable appetite)

    Secondary Outcome Measures

    Weight loss
    Appetite will be quantified weekly during the 12 weeks of treatment
    Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist
    The compliance with the 3 arms of treatment will be investigated. Diet complience will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist.

    Full Information

    First Posted
    September 25, 2015
    Last Updated
    September 30, 2015
    Sponsor
    Abdel Kadar Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02564627
    Brief Title
    PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure
    Official Title
    Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 With an Ambulatory Self-applied Patch vs PENS of Dermatome T6 With Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abdel Kadar Clinic

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups: PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet Only 1200Kcal/day diet The effect on appetite and weight loss will be investigated.
    Detailed Description
    A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups: PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet PENS of dermatome T6 with conventional procedure (weekly stimulation in the Outpatient Clinic) + 1200Kcal/day diet Only 1200Kcal/day diet The effect on appetite and weight loss will be investigated.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Self-applied patch
    Arm Type
    Experimental
    Arm Description
    The patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed.
    Arm Title
    Conventional procedure
    Arm Type
    Active Comparator
    Arm Description
    The patient will attend weekly the Outpatient Clinic for receiving the PENS of dermatome T6. The procedure will be performed by the Medicine Doctor. A 1200 Kcal/day diet will be also prescribed.
    Arm Title
    1200 Kcal/day diet
    Arm Type
    Other
    Arm Description
    A 1200 Kcal/day diet will be also prescribed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Self-applied patch
    Intervention Description
    An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional procedure
    Intervention Description
    PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    1200 Kcal/day diet
    Intervention Description
    A 1200 Kcal/day diet will be prescribed.
    Primary Outcome Measure Information:
    Title
    Appetite will be quantified with a visual analogic scale
    Description
    Appetite will be quantified weekly during the 12 weeks of treatment. Appetite will be quantified with a visual analogic scale (0= absence of appetite, 10=uncontrollable appetite)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Weight loss
    Description
    Appetite will be quantified weekly during the 12 weeks of treatment
    Time Frame
    12 weeks
    Title
    Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist
    Description
    The compliance with the 3 arms of treatment will be investigated. Diet complience will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Moderately obese patients (BMI 30-39 kg/m2) Exclusion Criteria: Endocrinological diseases causing obesity Heart pacemaker Previous bariatric procedure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohammed Abdel Kadar
    Organizational Affiliation
    Kadar Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27289457
    Citation
    Abdel-Kadar M. Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 with an Ambulatory Self-applied Patch vs PENS of Dermatome T6 with Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients. Obes Surg. 2016 Dec;26(12):2899-2905. doi: 10.1007/s11695-016-2214-0.
    Results Reference
    derived

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    PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

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