Weight LossPhase 3NCT02564627
PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure
A Phase 3 study testing Self-applied patch, Conventional procedure and 1200 Kcal/day diet in people with Weight Loss, run by Abdel Kadar Clinic.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- Self-applied patch, Conventional procedure and 1200 Kcal/day diet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderately obese patients (BMI 30-39 kg/m2)
Who cannot join
- Endocrinological diseases causing obesity
- Heart pacemaker
- Previous bariatric procedure
About this study
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
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.
Read the 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.
- Conditions
- Weight Loss
- Being tested
- Self-applied patch, Conventional procedure, 1200 Kcal/day diet
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-applied patchProcedure or surgery
An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.
Conventional procedureProcedure or surgery
PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.
1200 Kcal/day dietDietary supplement
A 1200 Kcal/day diet will be prescribed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Self-applied patch; Dietary 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. Receives: Procedure: Conventional procedure; Dietary Supplement: 1200 Kcal/day diet |
| 1200 Kcal/day diet | Other | A 1200 Kcal/day diet will be also prescribed. Receives: Dietary Supplement: 1200 Kcal/day diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (2)
Weight loss
Appetite will be quantified weekly during the 12 weeks of treatment
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdel Kadar Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Abdel Kadar, Principal investigator, Kadar Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564627
- Sponsor's protocol ID
- KC15-02
- Status last verified
- Sep 2015
- First submitted
- 25 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27289457
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02564627
- Acronym / sponsor ID
- KC15-02
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Abdel Kadar ClinicUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-applied patch | Experimental | Procedure: Self-applied patch, Dietary Supplement: 1200 Kcal/day dietThe patients will use a self-applied patch weekly for PENS of dermatome T6. A 1200 Kcal/day diet will be also prescribed. |
| Conventional procedure | Active comparator | Procedure: Conventional procedure, Dietary Supplement: 1200 Kcal/day dietThe 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. |
| 1200 Kcal/day diet | Other | Dietary Supplement: 1200 Kcal/day dietA 1200 Kcal/day diet will be also prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderately obese patients (BMI 30-39 kg/m2)
Key exclusion criteria (3 listed)
- Endocrinological diseases causing obesity
- Heart pacemaker
- Previous bariatric procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-applied patchAn ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6. | Procedure or surgery | Self-applied patch |
| Conventional procedurePENS of dermatome T6 will be applied by the MD in the Outpatient Clinic. | Procedure or surgery | Conventional procedure |
| 1200 Kcal/day dietA 1200 Kcal/day diet will be prescribed. | Dietary supplement | 1200 Kcal/day diet, Conventional procedure, Self-applied patch |
Primary outcome
Appetite will be quantified with a visual analogic scale
Time frame: 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)
2 secondary outcomes
Weight loss
Time frame: 12 weeks
Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Derived from this study: PubMed 27289457Abdel-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.
Related trials for Weight Loss
Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Abdel Kadar principal investigator
Kadar Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-applied patch, Conventional procedure and 1200 Kcal/day diet in people with Weight Loss, run by Abdel Kadar Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite will be quantified with a visual analogic scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02564627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.