NCT04553627

Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis

Allergan IIT-2019-10713 Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Riverchase Dermatology · Academic / Other
• Sex: Female
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of cryolipolysis of the medial infragluteal fold to create the appearance of a gluteal lift.

Detailed description

In this study, the safety and the efficacy of ZELTIQ's technology will be evaluated for the non-invasive fat reduction of the medial infragluteal folds on a small group of subjects. This is a feasibility study to determine if cryolipolysis in this area produces a desirable lifted appearance to the buttocks. Typically, a lifted more youthful appearance is obtained through surgical means. Study participants will be recruited from the population of patients who have suitable, treatable subcutaneous fat on the medial infragluteal folds and desire a lifted appearance. Subjects will receive treatments with a cooled cup cryolipolysis applicator from the CoolAdvantage family of applicators (cooled cup vacuum applicator). Treatments will be performed with a treatment temperature of - 11°C for up to 35 minutes. Subjects will complete all study-required follow-up visits, including an 8-week follow-up which may include a second treatment session, as well as a 12-week post final treatment follow-up visit.

Conditions

• Subcutaneous Fat

Interventions

Type	Name	Description
DEVICE	ZELTIQ thermoelectric device	This is a feasibility study to determine if cryolipolysis in this area produces a desirable lifted appearance to the buttocks. Typically, a lifted more youthful appearance is obtained through surgical means. Study participants will be recruited from the population of patients who have suitable, treatable subcutaneous fat on the medial infragluteal folds and desire a lifted appearance. Subjects will receive treatments with a cooled cup cryolipolysis applicator from the CoolAdvantage family of applicators (cooled cup vacuum applicator). Treatments will be performed with a treatment temperature of - 11°C for up to 35 minutes. Subjects will complete all study-required follow-up visits, including an 8-week follow-up which may include a second treatment session, as well as a 12-week post final treatment follow-up visit

Timeline

• Start date: 2020-07-15
• Primary completion: 2021-04-30
• Completion: 2021-05-30
• First posted: 2020-09-17
• Last updated: 2020-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study