RECRUITING

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions

Conditions

Wrinkle Fine Lines Crepey Skin Acne Scars Active Acne Enlarged Pores Stretch Mark Loose Skin

Quick Navigation

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

The goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Official Title

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions.

Quick Facts

Study Start:2023-07-24

Study Completion:2024-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05987319

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:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* A healthy, non-smoking male or female between the age of 22-65 years old. * Fitzpatrick skin type I to VI. * Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study. * Understands and accepts the obligation and is logistically able to be present for all visits. * Is willing to comply with all requirements of the study and sign the informed consent document.	* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study. * The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 1 month prior to entering this study. * The subject has a pacemaker. * The subject had previous use of gold thread skin rejuvenation. * The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated). * The subject has a metal implant that interferes with the transmission of energy to the electrical field. * The subject has any embedded electronic devices that give or receive a signal. * The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant. * The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area. * The subject is allergic to gold. * The subject has an unrealistic expectation of the results: this is not plastic surgery, and all subjects should be fully informed of the treatment's expected results. * The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area. * The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated: this treatment will be ineffective. * The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle. * The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti- inflammatories or anticoagulants. * The subject has a history of bleeding coagulopathies. * The subject is allergic to topical anesthetic. * The subject has any of the following conditions: * Diabetes * Epilepsy * Autoimmune disease * Herpes simplex * HIV * Hypertension * Dermatitis * The subject has keloid formation propensity. * Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks. * The subject has any condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound study results or may interfere.

Inclusion Criteria

Exclusion Criteria

* A healthy, non-smoking male or female between the age of 22-65 years old.
* Fitzpatrick skin type I to VI.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.

* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 1 month prior to entering this study.
* The subject has a pacemaker.
* The subject had previous use of gold thread skin rejuvenation.
* The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated).
* The subject has a metal implant that interferes with the transmission of energy to the electrical field.
* The subject has any embedded electronic devices that give or receive a signal.
* The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant.
* The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area.
* The subject is allergic to gold.
* The subject has an unrealistic expectation of the results: this is not plastic surgery, and all subjects should be fully informed of the treatment's expected results.
* The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
* The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated: this treatment will be ineffective.
* The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
* The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti- inflammatories or anticoagulants.
* The subject has a history of bleeding coagulopathies.
* The subject is allergic to topical anesthetic.
* The subject has any of the following conditions:
* Diabetes
* Epilepsy
* Autoimmune disease
* Herpes simplex
* HIV
* Hypertension
* Dermatitis
* The subject has keloid formation propensity.
* Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
* The subject has any condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound study results or may interfere.

Contacts and Locations

Study Contact

Jamie Trimper

CONTACT

9782564200

jamie.trimper@cynosure.com

Study Locations (Sites)

Cynosure, Inc.

Westford, Massachusetts, 01886

United States

Collaborators and Investigators

Sponsor: Cynosure, Inc.

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 Date2023-07-24

Study Completion Date2024-08

Study Record Updates

Study Start Date2023-07-24

Study Completion Date2024-08

Terms related to this study

Additional Relevant MeSH Terms

Wrinkle
Fine Lines
Crepey Skin
Acne Scars
Active Acne
Enlarged Pores
Stretch Mark
Loose Skin