Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars. (NCT01883414) | Clinical Trial Compass
TerminatedNot Applicable
Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars.
Stopped: Lack of resources to manage trial; lack of efficacy.
United States14 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female, age 18 to 70 years.
✓. Subject in good health.
✓. Subjects will have regularly shaped surgical scars on the chest, abdomen or back that are at least 4 cm long, are no wider than 1 cm, and are at least 6 months old.
✓. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Exclusion criteria
✕. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
✕. Presence of an active systemic or local skin disease that may affect wound healing.
✕. Allergy to any pain medications used in the study (lidocaine, NSAIDs, narcotics, etc.)
✕. Severe solar elastosis.
✕. Open wounds or lesions in the area(s) to be treated.
✕. Severe or cystic acne on the area(s) to be treated.
✕. Presence of a metal stent or implant in the area(s) to be treated.
What they're measuring
1
The primary endpoint is improvement in appearance of scar tissue as determined by a masked, qualitative assessment of photographs at 90-days post-treatment time points comparing the treated to untreated side of the scar.