NCT01883414

Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Ulthera, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Up to 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after treatment. Study images will be obtained before treatment, immediately after treatment and at each follow-up visit.

Detailed description

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® system to improve the appearance of scar tissue on the neck, abdomen or back. Changes from baseline of the Patient Observer Scar Assessment Scale score will be assessed at study follow-up visits. Images will be obtained prior to treatment and at each follow up visit. Patient satisfaction questionnaires will also be obtained.

Conditions

• Surgical Scar

Interventions

Type	Name	Description
DEVICE	Ultherapy™	All subjects will receive an Ultherapy™ treatment at triple depth using the 4-4.5mm, 7- 3.0mm, 10-1.5mm transducers on one half of the scar and no treatment on the other half of the scar. Treatments will be provided to the defined scar area, treating with a density of lines that is equivalent to 30 lines per transducer per 2.5cm in scar length for a total of 90 lines in a 2.5cm X 2.5cm square area.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-06-21
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States