NCT06274177

Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation

Evaluation of the Safety and Efficacy of the BTL-785F Device for Non-invasive Submental Fat Reduction and Neck Rejuvenation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.

Detailed description

This is a multi center single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits. At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient. The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device. Safety measures will include documentation of adverse events (AE) during and after the procedures and if needed medical assistance.

Conditions

• Fat Burn

Interventions

Type	Name	Description
DEVICE	BTL-785-7	Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment

Timeline

• Start date: 2023-07-26
• Primary completion: 2024-08-04
• Completion: 2024-09-12
• First posted: 2024-02-23
• Last updated: 2024-10-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study