Back to resultsSafety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
Primary Purpose
Overweight, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
BTL-703 (Treatment group)
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 22 years
- Voluntarily signed informed consent form
Exclusion Criteria:
- Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- Diabetics dependent on insulin or oral hypoglycemic medications
- Known cardiovascular disease such as arrhythmias, congestive heart failure
- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction
- Medical, physical or other contraindications for body sculpting/ weight loss
- Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
- Any medical condition known to affect weight levels and/or to cause bloating or swelling
- Active infection, wound or other external trauma to the area to be treated
- Pregnant, breast feeding, or planning pregnant before the end of the study
- Serious mental health illness
- Active or recurrent cancer or current chemotherapy and/or radiation treatment
- Negative affection to heat
Sites / Locations
- Aesthe ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Treated group of subjects, serves as its own control
Outcomes
Primary Outcome Measures
Waist circumference reduction
The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline.
Secondary Outcome Measures
Serious adverse events following the treatment
Occurrence of serious adverse events will be followed throughout the whole study.
Photo evaluation
Correct identification of the pre- and post-treatment photos by blinded evaluators.
Subject Satisfaction
Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit.
Therapy discomfort
Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03545360
Brief Title
Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
Official Title
Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Treated group of subjects, serves as its own control
Intervention Type
Device
Intervention Name(s)
BTL-703 (Treatment group)
Intervention Description
Treatment with BTL-703 device
Primary Outcome Measure Information:
Title
Waist circumference reduction
Description
The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Serious adverse events following the treatment
Description
Occurrence of serious adverse events will be followed throughout the whole study.
Time Frame
5 months
Title
Photo evaluation
Description
Correct identification of the pre- and post-treatment photos by blinded evaluators.
Time Frame
5 months
Title
Subject Satisfaction
Description
Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit.
Time Frame
5 months
Title
Therapy discomfort
Description
Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 22 years
Voluntarily signed informed consent form
Exclusion Criteria:
Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
Diabetics dependent on insulin or oral hypoglycemic medications
Known cardiovascular disease such as arrhythmias, congestive heart failure
Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction
Medical, physical or other contraindications for body sculpting/ weight loss
Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
Any medical condition known to affect weight levels and/or to cause bloating or swelling
Active infection, wound or other external trauma to the area to be treated
Pregnant, breast feeding, or planning pregnant before the end of the study
Serious mental health illness
Active or recurrent cancer or current chemotherapy and/or radiation treatment
Negative affection to heat
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgi Petkov
Phone
32 62 22 52
Ext
+359
Email
petkov@btlnet.com
Facility Information:
Facility Name
Aesthe Clinic
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radina Denkova, MD
Email
aestheclinic@abv.bg
First Name & Middle Initial & Last Name & Degree
Radina Denkova, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
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