NCT03433417

Performance Evaluation of the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

A Single-center, Prospective, Non-randomized, Open-label Clinical Study to Evaluate the Performance of the truSculpt Radiofrequency Device for Non-invasive Fat Reduction in Abdominal Tissue in Subjects Who Are Scheduled for Abdominoplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cutera Inc. · Industry
• Sex: All
• Age: 24 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Clinical Study to Evaluate the Performance the truSculpt Radiofrequency Device for Lipolysis of Abdominal Fat

Detailed description

A single-center, prospective, non-randomized, open-label study to evaluate the truSculpt Radiofrequency Device for non-invasive fat reduction in abdominal tissue for up to 14 subjects. Measurement will be histological evaluation of tissue for selective fat necrosis, with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated contralateral control.

Conditions

• Body Fat

Interventions

Type	Name	Description
DEVICE	Cutera truSculpt	One truSculpt treatment delivered 0 to 90 days before scheduled Abdominoplasty to one side of the tissue to be removed during abdominoplasty

Timeline

• Start date: 2017-06-15
• Primary completion: 2018-03-15
• Completion: 2018-03-15
• First posted: 2018-02-14
• Last updated: 2023-03-17
• Results posted: 2023-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study