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Procedure

Profound Matrix for Chronic Wounds

N/A

Recruiting

Led By Konika Schallen

Research Sponsored by Candela Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1-month follow-up and 3-month follow-up, up to 14 weeks.

Awards & highlights

Study Summary

This trial tests whether a new medical device is safe & effective to treat chronic wounds.

Who is the study for?

This trial is for healthy adults aged 18-75 with any skin type who want to improve loose skin or wrinkles. Participants must be willing to undergo Profound Matrix treatments, follow the study schedule, and allow their photos to be used. Exclusions include pregnancy, certain implants, active cancer treatment within a year, severe conditions like heart disorders or immune suppression, untreated herpes in the area, poor wound healing history, recent aesthetic procedures in the area.Check my eligibility

What is being tested?

The Profound Matrix system is being tested for its safety and effectiveness on improving skin appearance. This non-randomized trial will use different applicators (Sublime/Sublative RF/Matrix Pro) across multiple centers without comparing it to other treatments.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the treatment site, redness or swelling post-treatment; risk of burns from heat-based devices; temporary changes in pigmentation; and rare cases of scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1-month follow-up and 3-month follow-up, up to 14 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1-month follow-up and 3-month follow-up, up to 14 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1-month follow-up and 3-month follow-up, up to 14 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Investigator Global Aesthetic Improvement Scale (IGAIS)

Numerical Rating Scale (NRS)

Post-treatment Assessment Severity Scale

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Study subjects may be treated with any of the Profound Matrix applicators: Sublime, Sublative RF and/or Matrix Pro. Treatments may include combination of applicators or additional commercial devices per PI discretion.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Candela CorporationLead Sponsor

19 Previous Clinical Trials

1,465 Total Patients Enrolled

Konika SchallenPrincipal InvestigatorCandela Institue for Exellence

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be an eligible participant in this research endeavor?

"This clinical trial is recruiting up to 500 participants that present with sagging skin and are within the age range of 18-75 years."

Answered by AI

How many participants are taking part in this research endeavor?

"Affirmative. Clinicaltrials.gov documents that this experiment, which was initially posted on May 24th 2022, is currently recruiting participants. Approximately 500 people need to be enrolled from 5 different research centres."

Answered by AI

Are there any open enrolment possibilities for this trial?

"Affirmative, according to clinicaltrials.gov this trial is actively recruiting. It was first posted on 24th May 2022 and has since been modified as recently as 4th December 2023. The study requires 500 volunteers from 5 different sites in total."

Answered by AI

Are participants of this research initiative aged 40 or over?

"Eligibility criteria for this trial requires that participants must have surpassed the age of consent and be under 75 years old."

Answered by AI

How many venues are currently hosting this research endeavor?

"Patients can enrol in this medical trial at Waterfront Skin and Laser (Vancouver), Gerrish MedEsthetics (Vienna) Candela European Institue of Excellence (Madrid), as well as 5 other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System

2022. "Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06157567.