RECRUITING

Mechanical Coring to Achieve Directional Skin Tightening

Conditions

Skin Tightening Healthy Volunteers Rhytides Wrinkles Loose Skin Skin Laxity Mechanical Coring Robotic Coring Skin Scarring Scars Stretch marks

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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

The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.

Official Title

Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening

Quick Facts

Study Start:2021-02-14

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04910945

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:30 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy, male or female subjects between 30 and 70 years of age. 2. Able to read, understand, and voluntarily provide written Informed Consent. 3. Able and willing to comply with the treatment/follow-up schedule and requirements. 4. Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline. 5. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.	1. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months. 2. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area. 3. History of keloid formation 4. Active smoker or having quit smoking in the last 3 months. 5. Active, chronic, or recurrent infection 6. Compromised immune and/or healing system (e.g. diabetes) 7. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study. 8. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements. 9. Pregnant or breastfeeding 10. Any indication that may cause excessive bleeding, e.g., anticoagulants. 11. Carcinoma, melanoma, or any other cancerous condition in the last 6 months. 12. Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA). 13. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device 14. Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.

Inclusion Criteria

Exclusion Criteria

1. Healthy, male or female subjects between 30 and 70 years of age.
2. Able to read, understand, and voluntarily provide written Informed Consent.
3. Able and willing to comply with the treatment/follow-up schedule and requirements.
4. Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
5. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.

1. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months.
2. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area.
3. History of keloid formation
4. Active smoker or having quit smoking in the last 3 months.
5. Active, chronic, or recurrent infection
6. Compromised immune and/or healing system (e.g. diabetes)
7. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
8. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements.
9. Pregnant or breastfeeding
10. Any indication that may cause excessive bleeding, e.g., anticoagulants.
11. Carcinoma, melanoma, or any other cancerous condition in the last 6 months.
12. Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA).
13. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device
14. Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.

Contacts and Locations

Study Contact

Matthew Gronski, PhD

CONTACT

888-907-0115

mgronski@venusconcept.com

Principal Investigator

Matthew Gronski, PhD

STUDY_DIRECTOR

Venus Concept

Study Locations (Sites)

Berman Skin Institute

Los Altos, California, 94022

United States

Le's Aesthetics

San Jose, California, 95112

United States

DeNova Research

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Venus Concept

Matthew Gronski, PhD, STUDY_DIRECTOR, Venus Concept

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 Date2021-02-14

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-02-14

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

Rhytides
Wrinkles
Loose Skin
Skin Laxity
Mechanical Coring
Robotic Coring
Skin Scarring
Scars
Stretch marks

Additional Relevant MeSH Terms

Skin Tightening
Healthy Volunteers