PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure

Abdel Kadar Clinic

Status and phase

Completed

Phase 3

Conditions

Weight Loss

Treatments

Dietary Supplement: 1200 Kcal/day diet

Procedure: Conventional procedure

Procedure: Self-applied patch

Study type

Interventional

Funder types

Other

Identifiers

NCT02564627

KC15-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Endocrinological diseases causing obesity
Heart pacemaker
Previous bariatric procedure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Self-applied patch

Experimental group

Description:

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

Treatment:

Procedure: Self-applied patch

Dietary Supplement: 1200 Kcal/day diet

Conventional procedure

Active Comparator group

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.

Treatment:

Procedure: Conventional procedure

Dietary Supplement: 1200 Kcal/day diet

1200 Kcal/day diet

Other group

Description:

A 1200 Kcal/day diet will be also prescribed.

Treatment:

Dietary Supplement: 1200 Kcal/day diet