NCT04406935

Evaluation of the Safety and Efficacy of the NuEra Tight for Abdominal Circumference Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group

Detailed description

The study design to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group. each group has a different radio-frequency. The study hypothesis is that NuEra Tight is safe and will cause a reduction in abdominal circumferential after treatment and at 12 week post last treatment within each treatment group.

Conditions

• Circumferential Reduction

Interventions

Type	Name	Description
DEVICE	treatment with the study device (NuEra)	Multi-arm, prospective, multi-center, baseline-controlled study: Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2020-05-29
• Last updated: 2022-06-01

Locations

2 sites across 1 country: United States