NCT02564627

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_3

Status
completed

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

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

September 25, 2015

Last Update Submit

September 30, 2015

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 weeks

Secondary Outcomes (2)

  • Weight loss

    12 weeks

  • Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist

    12 weeks

Study Arms (3)

Self-applied patch

EXPERIMENTAL

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

Procedure: Self-applied patchDietary Supplement: 1200 Kcal/day diet

Conventional procedure

ACTIVE COMPARATOR

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.

Procedure: Conventional procedureDietary Supplement: 1200 Kcal/day diet

1200 Kcal/day diet

OTHER

A 1200 Kcal/day diet will be also prescribed.

Dietary Supplement: 1200 Kcal/day diet

Interventions

Self-applied patchPROCEDURE

An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.

Self-applied patch
Conventional procedurePROCEDURE

PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.

Conventional procedure
1200 Kcal/day dietDIETARY_SUPPLEMENT

A 1200 Kcal/day diet will be prescribed.

1200 Kcal/day dietConventional procedureSelf-applied patch

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27289457DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Mohammed Abdel Kadar

    Kadar Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2015

First Posted

October 1, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09