iCOOL_0260-0248
Research type
Research Study
Full title
International CoolSculpting: Prospective, Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
IRAS ID
261064
Contact name
Sach Mohan
Contact email
Sponsor organisation
ALLERGAN SALES, LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
CoolSculpting is a nonsurgical (cryolipolysis procedure) clinically proven treatment that selectively reduces unwanted fat using a patented cooling technology.
Most clinical studies on CoolSculpting have been conducted at US sites; therefore, only a limited number of subjects have been treated and studied at international sites. There is also not enough information regarding patient opinion related to the CoolSculpting procedure and specifically the psychosocial impact of localized fat. Therefore, Allergan would like to assess the psychosocial impact of treating subjects with CoolSculpting on the abdomen and flank.
Subjects will undergo CoolSculpting treatment(s) in an outpatient clinical setting. A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage.
The study will include Adult subjects (healthy volunteers, male or female ≥22 years and ≤65 years of age) that have clearly visible fat in the flanks and/or abdomen, which in the investigator’s opinion, may benefit from the treatment. The study population for the iCOOL study includes patients who meet the inclusion/exclusion criteria stated in the study protocol.
The study will be conducted at up to 8 sites globally and approximately 100 patients will be enrolled in this trial.REC name
South West - Frenchay Research Ethics Committee
REC reference
19/SW/0047
Date of REC Opinion
7 Mar 2019
REC opinion
Favourable Opinion