Skin Laxity Clinical Trial
Official title:
Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Verified date | September 2023 |
Source | Apyx Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. All adverse events and expected treatment effects will be documented. Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.
Status | Active, not recruiting |
Enrollment | 5 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients who are scheduled for a procedure involving the use of Renuvion for the contraction of subcutaneous soft tissue. Patients undergoing procedures involving Renuvion alone and/or Renuvion following liposuction will be included. - Patients who have acceptable cardiopulmonary health for outpatient surgery. - Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits. - Willing to release rights for the use of study photos, including in potential publication. - Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit. - Able to read, understand, sign and date the informed consent document (English only). Exclusion Criteria: - BMI of greater than 35. - Diabetes mellitus with A1C score >7. - Active cigarette smokers or nicotine vape users. - History of connective tissue disease (Ehlers Danlos, Cutis Laxa, Pseudoxanthoma Elasticum, Marfan's, etc.) - Patients who, in the opinion of the investigator, is not an appropriate candidate for the study. - Patients requiring a concomitant procedure in the Renuvion treatment area that could impact the ultrasound measurements or the effectiveness results. |
Country | Name | City | State |
---|---|---|---|
United States | Pearl Plastic Surgery | Olympia | Washington |
Lead Sponsor | Collaborator |
---|---|
Apyx Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Analysis of adverse events | Day 365 | |
Primary | Analysis of contraction | Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images. | Day 365 | |
Secondary | IPR Review | Improvement in appearance of skin laxity in the treatment area assessed by selection of the correct post-treatment image as determined by a masked, qualitative assessment of photographs by blinded independent reviewers | Day 365 | |
Secondary | Physician Global Aesthetic Improvement | The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area | Day 365 | |
Secondary | Subject Global Aesthetic Improvement | The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area | Day 365 | |
Secondary | Patient Satisfaction | The subject will complete a Patient Satisfaction Questionnaire (PSQ) | Day 365 | |
Secondary | Energy Delivered | Analysis of energy delivered (J/cm2) | Day 0 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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