NCT04000945

Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits

Detailed description

This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.

Conditions

• Improvement of Abdomen Appearance

Interventions

Type	Name	Description
DEVICE	BTL-899	Treatment with BTL-899 device, 3 therapies
DEVICE	Sham	Sham treatment with BTL-899 device, 3 visits

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-12-03
• Completion: 2019-12-31
• First posted: 2019-06-27
• Last updated: 2019-06-27

Locations

1 site across 1 country: Bulgaria