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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545360
• Other study ID #: BTL-703-001
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2018
• Source: BTL Industries Ltd.
• Contact: Georgi Petkov
• Phone: 32 62 22 52
• Email: petkov[@]btlnet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Device:
• BTL-703 (Treatment group)
Treatment with BTL-703 device

Locations

Country	Name	City	State
Bulgaria	Aesthe Clinic	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

Bulgaria, 

Outcome

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