NCT05359614

Coolsculpting With Cooltone Verses Coolsculpting Alone for the Banana Roll Area

A Single-centered Randomized Single-blinded Clinical Trial to Evaluate Efficacy and Safety of Sequential Treatment of CoolSculpting Elite With CoolTone vs. CoolSculpting Elite Alone in Treating the Banana Roll Region

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: Female
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

to evaluate the benefit and efficacy of CoolSculpting Elite study treatments versus CoolSculpting Elite study treatments followed by a series CoolTone for underneath the buttocks (also known as the banana roll).

Detailed description

Investigate safety and efficacy of CoolSculpting Elite treatments for underneath the buttocks (also known as the banana roll) versus sequential treatments of CoolSculpting Elite and CoolTone for the banana roll region.

Conditions

• Improved Appearance of the Banana Roll Region

Interventions

Type	Name	Description
DEVICE	CoolSculpting Elite combined with CoolTone Treatments	Coolsculpting treatment combined with Cooltone treatments for the banana roll region of the buttocks.
DEVICE	CoolSculpting Elite	Coolsculpting treatment alone for the banana roll region of the buttocks

Timeline

• Start date: 2022-03-14
• Primary completion: 2022-08-30
• Completion: 2022-09-30
• First posted: 2022-05-04
• Last updated: 2022-05-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study