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

BTL

Status: Unknown

Conditions: Overweight; Obesity

Treatments: Device: BTL-703 (Treatment group)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03545360

BTL-703-001

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Treatment Group

Experimental group

Description:

Treated group of subjects, serves as its own control

Treatment:

Device: BTL-703 (Treatment group)