Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis

Not Applicable

• Conditions: Obesity; Overweight
• Interventions: Device: BTL-703 (Treatment group)

• Registration Number: NCT03545360
• Lead Sponsor: BTL Industries Ltd.

Brief Summary

The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-28
• Status Verified: 2018-05
• Study First Submitted QC: 2018-06-01
• Last Update Submitted: 2018-06-01
• Study First Posted: 2018-06-04
• Last Update Posted: 2018-06-04
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	BTL-703 (Treatment group)	Treated group of subjects, serves as its own control

Primary Outcome Measures

Name	Time	Method
Waist circumference reduction	5 months	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

Name	Time	Method
Serious adverse events following the treatment	5 months	Occurrence of serious adverse events will be followed throughout the whole study.
Photo evaluation	5 months	Correct identification of the pre- and post-treatment photos by blinded evaluators.
Subject Satisfaction	5 months	Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit.
Therapy discomfort	2 months	Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire.

Trial Locations

Locations (1)

Aesthe Clinic; 🇧🇬 Sofia, Bulgaria