Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-05 @ 12:22 AM
Study NCT ID:
NCT02564627
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2015-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure
Sponsor:
Abdel Kadar Clinic
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: