PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

Phase 3

Completed

• Conditions: Weight Loss

• Registration Number: NCT02564627
• Lead Sponsor: Abdel Kadar Clinic

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.

Study Timeline

• Study Start: 2015-07
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-30
• Last Update Submitted: 2015-09-30
• Study First Posted: 2015-10-01
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Appetite will be quantified with a visual analogic scale	12 weeks	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

Name	Time	Method
Weight loss	12 weeks	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	12 weeks	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.