ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a non-randomized, multi-center, open-label clinical trial evaluating clinical feasibility treatments with the Profound Matrix system.

Official Title

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

Quick Facts

Study Start:2022-05-24

Study Completion:2028-05-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06157567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI. 2. Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or Matrix Pro applicator 3. Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements. 4. Willing to provide signed, informed consent to participate in the study 5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials (Subject identity will be masked).	1. Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding 2. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body 3. 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 4. Skin cancer in the treatment area or history of melanoma 5. History of current cancer and subject has undergone chemotherapy within the last 12 months 6. Severe concurrent conditions, such as cardiac disorders 7. Impaired immune system or use of immunosuppressive medications 8. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen 9. Poorly controlled endocrine disorders such as poorly controlled diabetes 10. Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds 11. History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin 12. History of collagen vascular disease or vasculitic disorders 13. Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine) 14. History of systemic corticosteroid therapy in past six months 15. Tattoos or permanent makeup in the intended treatment area 16. Excessively tanned skin 17. Facelift in the last 12 months 18. Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area 19. Neuromodulator injections (e.g. Botox®), collagen, non-permanent dermal filler, or fat injections or other methods of augmentation with injected bio-material in the treated area within the last 3 months 20. Permanent synthetic fillers (e.g. silicone) in the treatment area 21. Absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area 22. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study

Inclusion Criteria

Exclusion Criteria

1. Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
2. Willing to receive Profound Matrix treatments with any of the following applicators: Sublime, Sublative RF, and/or Matrix Pro applicator
3. Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
4. Willing to provide signed, informed consent to participate in the study
5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials (Subject identity will be masked).

1. Pregnant or planning to become pregnant, having given birth less than 3 months prior to enrollment into the study, and/or breast feeding
2. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body
3. 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
4. Skin cancer in the treatment area or history of melanoma
5. History of current cancer and subject has undergone chemotherapy within the last 12 months
6. Severe concurrent conditions, such as cardiac disorders
7. Impaired immune system or use of immunosuppressive medications
8. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
9. Poorly controlled endocrine disorders such as poorly controlled diabetes
10. Active skin condition in the treatment area such as skin infection, sores, psoriasis, eczema, rash, or open wounds
11. History of abnormal wound healing, keloid, or hypertrophic scar formation, as well as very thin or fragile skin
12. History of collagen vascular disease or vasculitic disorders
13. Known allergy to medication to be used during treatments such as allergy to topical anesthetic (e.g. lidocaine)
14. History of systemic corticosteroid therapy in past six months
15. Tattoos or permanent makeup in the intended treatment area
16. Excessively tanned skin
17. Facelift in the last 12 months
18. Aesthetics treatments/procedures (e.g. facial resurfacing and deep chemical peeling) within the last 4 months within the intended treatment area
19. Neuromodulator injections (e.g. Botox®), collagen, non-permanent dermal filler, or fat injections or other methods of augmentation with injected bio-material in the treated area within the last 3 months
20. Permanent synthetic fillers (e.g. silicone) in the treatment area
21. Absorbable facial threads within the last 1 year or non-absorbable facial threads within the intended treatment area
22. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study

Contacts and Locations

Principal Investigator

Konika Schallen, MD

PRINCIPAL_INVESTIGATOR

Candela Institue for Exellence

Study Locations (Sites)

Center for Morden Aesthetic Medicine

Jacksonville, Florida, 32207

United States

Candela Institue for Excellence

Marlborough, Massachusetts, 01752

United States

Concierge Medical Arts

Fayetteville, North Carolina, 28306

United States

Gerrish MedEsthetics

Vienna, Virginia, 22180

United States

Collaborators and Investigators

Sponsor: Candela Corporation

Konika Schallen, MD, PRINCIPAL_INVESTIGATOR, Candela Institue for Exellence

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-24

Study Completion Date2028-05-24

Study Record Updates

Study Start Date2022-05-24

Study Completion Date2028-05-24

Terms related to this study

Additional Relevant MeSH Terms

Skin Laxity
Wrinkle
Skin Condition