NCT05398159

Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen.

Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: InMode MD Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

At least 90 female and male subjects, from 6 investigational sites, aged 18-70 seeking non-invasive lipolysis and circumference reduction of abdomen will be enrolled. Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).

Detailed description

The goal of this prospective study is to evaluate Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen. The main questions are : * Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. * Safety of the Trim II treatment for lipolysis and abdominal circumference reduction Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.

Conditions

• Circumference Reduction of Abdomen

Interventions

Type	Name	Description
DEVICE	Trim II	Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Trim II hands-free applicator composed of 4 units applied to the abdominal area, using a single-use belt. Each treatment duration will be 45-60 minutes. Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2022-05-31
• Last updated: 2024-06-11
• Results posted: 2024-06-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study