Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks

NCT02569112 | Completed Results DMC

• 1 other identifier: CS0915
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect on the subject outcome using the combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar radiofrequency device with varipulse technology for the enhanced non-surgical treatment of skin laxity in the flank area.

Conditions

Adipose Tissue

Outcome Measures

Primary Outcomes (1)

• General Improvement in Skin Laxity of the Flank Area

  Independent reviewer to identify the six month post-treatment photograph of the flank area treated with multi-polar radiofrequency, pulsed electro-magnetic fields and vacuum suction using the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = Much worse and -3 = very much worse.

  6 months

Study Arms (2)

cryolipolysis

ACTIVE COMPARATOR

Each patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment.

Device: cryolipolysis

cryolipolysis, multipolar RF, varipulse

EXPERIMENTAL

Each patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment.

Device: multipolar RF, varipulse; Device: cryolipolysis

Interventions

multipolar RF, varipulse DEVICE

Multi-polar Radio frequency (RF) technology combining pulsed electro magnetic fields (PEMF) and mild suction stimulation (varipulse).

Also known as: Venus Legacy

cryolipolysis, multipolar RF, varipulse

cryolipolysis DEVICE

Cryolipolysis technology uses the sensitivity of fat cells to cold injury, causing them to freeze and undergo cellular apoptosis.

Also known as: CoolSculpt

cryolipolysis; cryolipolysis, multipolar RF, varipulse

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who can read, understand, and sign the Informed Consent Form.
• Subjects willing and able to comply with all study requirements.
• Subjects who have pre-scheduled a body contouring procedure.
• Subjects have clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
• Subjects have not had weight change exceeding 10 pounds in the preceding month.
• Subjects agree to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.

You may not qualify if:

• Subjects with active localized or systemic infections.
• Immuno-compromised subjects.
• Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
• In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
• Subjects with a history of radiation therapy to the treatment area.
• Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
• Subject has had a surgical procedure(s) in the area of intended treatment.
• Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
• Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
• Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Few Institute

Chicago, Illinois, 60611, United States

Location

Limitations and Caveats

This was a pilot study to evaluate the treatment combination.

Results Point of Contact

• Title: Dr. Yoni Iger
• Organization: Venus Concept Ltd.

yoni@venusconcept.com

8889070115

Study Officials

• Julius Few, MD

  Few Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both investigator and independent reviewer to determine which side of the body the multi-polar radiofrequency, pulsed-electromagnetic fields and vacuum therapy was applied.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants to receive cryolipolysis treatment on one side of their body and cryolipolysis plus multipolar radiofrequency with varipulse technology treatment on the other side of their body.

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: October 6, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 18, 2018
• Results First Posted: June 18, 2018

Record last verified: 2017-12

Locations

US (1)