Functional Usability and Feasibility Testing of the Profound Matrix™ System (NCT06192550) | Clinical Trial Compass
CompletedNot Applicable
Functional Usability and Feasibility Testing of the Profound Matrix™ System
United States, Israel193 participantsStarted 2020-10-28
Plain-language summary
This is a non-randomized, multi-center, open-label clinical trial evaluating the efficacy and clinical feasibility of the Profound Matrix device for electrocoagulation and for treatment of wrinkles and acne scars. Subjects will receive up to three (3) treatments with the Matrix Pro applicator or up to five (5) treatments with the Sublime and/or Sublative Radiofrequency (RF) applicators.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy Male or Female
. Age 18 to 75
. Subjects seeking treatment for facial, abdominal, or back wrinkles reduction, skin texture improvement and/or acne scars appearance improvement and willing to undergo RF treatments for improvement
. Presence of at least mild wrinkles or mild acne scars or uneven skin texture, as assessed by the Investigator
. Willingness to provide signed, informed consent to participate in the study
. Willingness to allow photography of treated areas, and to release their use for scientific/educational and/or promotional purposes
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Investigator Global Aesthetic Improvement Scale (GAIS): Perceived Improvement in Overall Appearance
. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
. Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment
. Current skin cancers in the treatment area or history of melanoma
. History of current cancer and subject has undergone chemotherapy within the last 12 months
. Severe concurrent conditions, such as cardiac disorders
. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen