Last updated: February 13, 2024
Sponsor: Venus Concept
Overall Status: Active - Recruiting
Phase
N/A
Condition
Healthy Volunteers
Treatment
VENUS AIME (RoboCor)
Clinical Study ID
NCT04910945
AI0620
Ages 30-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy, male or female subjects between 30 and 70 years of age.
- Able to read, understand, and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Women of childbearing age are required to be using a reliable method of birth controlat least 3 months prior to study enrollment and for the duration of the study and havea negative Urine Pregnancy test at baseline.
- Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects mayhave Fitzpatrick skin type V or VI.
Exclusion
Exclusion Criteria:
- Previous aesthetic (device and/or surgical) skin treatment in the treated areas (underarms and/or behind the ear) in the previous 6 months.
- Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for theduration of treatment, and tegaderm/glue application or any other synthetic materialin the treatment area.
- History of keloid formation
- Active smoker or having quit smoking in the last 3 months.
- Active, chronic, or recurrent infection
- Compromised immune and/or healing system (e.g. diabetes)
- Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture,Tegaderm or tensioning tape that will be used in the study.
- Co-morbid condition that could limit the ability to participate in the study or tocomply with follow-up requirements.
- Pregnant or breastfeeding
- Any indication that may cause excessive bleeding, e.g., anticoagulants.
- Carcinoma, melanoma, or any other cancerous condition in the last 6 months.
- Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA).
- Currently or in the last 1-month part of another clinical study of an investigationaldrug and/or experimental medical device
- Any issue that, at the discretion of the investigator would contra-indicate thesubject's participation.
Study Design
Total Participants: 70
Treatment Group(s): 1
Primary Treatment: VENUS AIME (RoboCor)
Phase:
Study Start date:
February 14, 2021
Estimated Completion Date:
August 31, 2025
Study Description
Connect with a study center
Berman Skin Institute
Los Altos, California 94022
United StatesActive - Recruiting
Le's Aesthetics
San Jose, California 95112
United StatesActive - Recruiting
DeNova Research
Chicago, Illinois 60611
United StatesCompleted
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