Clinical trial NCT05968495: Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Official title: Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Renuvion
Helium Plasma
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. Subjects may also have other body areas treated at the same time. Demographic information, medical history, and procedure details will be documented. Pre- and post-procedure care are per investigator standard of care and documented. Video may be taken during the procedure.

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. At baseline, photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area prior to study treatment.

Post-procedure care will be as per investigator standard of care and documented. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of Contraction From Baseline to Day 365
timeFrame: Baseline, Day 365
Secondary outcomes:
measure: IPR Review
timeFrame: Day 365
measure: Physician Global Aesthetic Improvement
timeFrame: Day 60, Day 90, Day 180, Day 270, Day 365
measure: Subject Global Aesthetic Improvement
timeFrame: Day 60, Day 90, Day 180, Day 270, Day 365
measure: Patient Satisfaction
timeFrame: Day 180, Day 270, Day 365
measure: Energy Delivered
timeFrame: Day 0
Other outcomes:
Locations:
city: Olympia
country: United States
facility: Pearl Plastic Surgery
state: Washington
Study officials:
affiliation: Investigator
name: Chris Nichols
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Dan Albershardt
role: PRINCIPAL_INVESTIGATOR
References: