NCT02553278

VelaShape and Contour I V3 for Abdominal Fat Reduction vs. Control

Clinical Study to Evaluate the Performances of Modified VelaShape and the Performance of Contour I V3 Devices for Abdominal Fat Reduction vs. Control

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I V3 device for non-invasive fat reduction vs. control. All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with VelaShape or Contour I V3 device. Each arm will be treated with a different device: Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I V3 device

Detailed description

Eligible subjects will undergo one treatment on one abdominal subarea. Another abdominal subarea will remain without treatment and will serve as a control. Biopsies from treated and untreated areas will be harvested during abdominoplasty and cultured.. Treatment with VelaShape will be performed to arm 1, and treatment with Contour I V3 will be performed to arm 2, according to the study protocol. Each arm will be divided into 6 sub-groups, according to the following time interval between VelaShape or UltraShape treatment to surgery: Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 10 days after treatment Sub-group 3: Surgery 20 days after treatment Sub-group 4: Surgery 30 days after treatment Sub-group 5: Surgery 60 days after treatment Sub-group 6: Surgery 90 days after treatment Each Sub-group contains up to 2 subjects.

Conditions

• Unwanted Abdomen Fat

Interventions

Type	Name	Description
DEVICE	VelaShape device	Modified VelaShape radiofrequency device for non invasive fat reduction treatment.
DEVICE	Contour I V3 device	Contour I V3 device are non invasive for fat reduction.

Timeline

• Start date: 2016-01-10
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-09-17
• Last updated: 2017-04-10

Locations

1 site across 1 country: Israel