NCT01976247

A Pilot Study Testing a Noninvasive Cryolipolysis Device Versus a High Intensity Focused Ultrasound Device for Fat Reduction

Pilot Study Comparing the Effectiveness of a Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device for Fat Reduction: A Randomized Control Trial

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.

Detailed description

At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.

Conditions

• Abdominal Fat

Interventions

Type	Name	Description
DEVICE	High Intensity Focused Ultrasound Device
DEVICE	Noninvasive Cryolipolysis Device

Timeline

• Start date: 2013-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2013-11-05
• Last updated: 2025-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study