BTL-9000 High Frequency Therapy for the Waist Circumferential Reduction

NCT02023398 | Completed

• 1 other identifier: BTL-9000 HFT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 HFT in achieving 3 cm or greater average waist circumferential reduction in HFT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.

Conditions

Circumferential Reduction; Waist Circumferential Reduction

Keywords

High Frequency; Waist circumferential reduction

Outcome Measures

Primary Outcomes (1)

• Waist Circumference Reduction

  The subjects in the HFT group whose average post-treatment waist circumference shows reduction of 3 cm or greater across the waistline relative to the base line assessment and their mean waist circumferential reduction is 1 cm or greater than the average circumferential reduction of Placebo group are considered to meet the study primary outcome success criteria.

  1 month follow up after 5 once-a-week treatments

Secondary Outcomes (1)

• Adverse Events

  1 month follow up

Study Arms (2)

HFT group

EXPERIMENTAL

Subjects in the High Frequency Therapy (HFT) group will be treated with the BTL-9000 HFT

Device: BTL-9000 HFT

Placebo group

PLACEBO COMPARATOR

Subjects in the Placebo group with be treated with the sham BTL-9000 HFT

Device: sham BTL-9000 HFT

Interventions

BTL-9000 HFT DEVICE

Deep tissue heating with the BTL-9000 HFT for HFT group

Also known as: BTL-9000 High Frequency Therapy

HFT group

sham BTL-9000 HFT DEVICE

sham deep tissue heating with BTL-9000 HFT in Placebo group

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area
• Body Mass Index (BMI) of 25 to 35 kg/m2.
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.

You may not qualify if:

• \- 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.
• Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
• Prior surgical interventions for body sculpting of abdomen 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
• Negative affection to heat
• Active or recurrent cancer or current chemotherapy and/or radiation treatment

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Polyklinika Mytna

Bratislava, Slovakia

Location

Study Officials

• Iveta Hasova, MD

  Polyklinaka Mytna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 30, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

SL (1)