NCT06283056

RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite

Radiofrequency Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: InMode MD Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits.

Detailed description

The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits. Prospective, open-label, baseline-controlled, clinical study to evaluate the Morpheus8 device for treatment of cellulite, skin laxity, and subcutaneous fat deposits of the thighs. Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion.

Conditions

• Cellulitis of Leg

Interventions

Type	Name	Description
DEVICE	Device treatment	InMode RF system with Morpheus8 Body (up to 7mm depth) Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion..each subject is approximately 9 months (including screening, two treatments (2 months apart) and 3 follow-up visits at 1 month, 3 months, and 6 months post treatment.

Timeline

• Start date: 2022-06-16
• Primary completion: 2024-10-02
• Completion: 2025-04-01
• First posted: 2024-02-28
• Last updated: 2025-10-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study