Evaluation of the Safety and Precursors of Efficacy (NCT02098811) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Safety and Precursors of Efficacy
United States10 participantsStarted 2013-06
Plain-language summary
The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.
Who can participate
Age range20 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-smoking subjects between ages of 20-55 years of age presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
* Subjects (Group 2 and 3) who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
* Understand and accept the obligation associated with the procedure
* Subjects with Fitzpatrick skin types I to VI.
* Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, as outlined for each group and defined in section 6.0.
* Subjects must agree to maintain the same diet and exercise regime throughout the study
Exclusion Criteria:
* Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
* A history of allergic reactions to medications or anesthesia required for the procedure
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
* Intolerance to anesthesia or medications to be prescribed before or after the procedure.
* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
* Taking medications that are phot…
What they're measuring
1
Biopsy of Tissue Sample as a Measure of Effectiveness
Timeframe: 6 months post treatment
2
Ultrasound Measurement to Evaluate Reduction of Fat