Back to resultsMeasuring Renuvion Soft Tissue Contraction Using Ultrasound
Primary Purpose
Skin Laxity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renuvion APR Handpiece
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Renuvion, Helium Plasma
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.
Sites / Locations
- Pearl Plastic Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renuvion APR System Treatment
Arm Description
Subjects 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.
Outcomes
Primary Outcome Measures
Analysis of contraction
Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images.
Secondary Outcome Measures
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
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
Subject Global Aesthetic Improvement
The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area
Patient Satisfaction
The subject will complete a Patient Satisfaction Questionnaire (PSQ)
Energy Delivered
Analysis of energy delivered (J/cm2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05968495
Brief Title
Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Official Title
Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apyx Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Renuvion, Helium Plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renuvion APR System Treatment
Arm Type
Experimental
Arm Description
Subjects 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.
Intervention Type
Device
Intervention Name(s)
Renuvion APR Handpiece
Intervention Description
The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Primary Outcome Measure Information:
Title
Analysis of contraction
Description
Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images.
Time Frame
Day 365
Secondary Outcome Measure Information:
Title
IPR Review
Description
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
Time Frame
Day 365
Title
Physician Global Aesthetic Improvement
Description
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
Time Frame
Day 365
Title
Subject Global Aesthetic Improvement
Description
The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area
Time Frame
Day 365
Title
Patient Satisfaction
Description
The subject will complete a Patient Satisfaction Questionnaire (PSQ)
Time Frame
Day 365
Title
Energy Delivered
Description
Analysis of energy delivered (J/cm2)
Time Frame
Day 0
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Analysis of adverse events
Time Frame
Day 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Nichols
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Albershardt
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pearl Plastic Surgery
City
Olympia
State/Province
Washington
ZIP/Postal Code
98501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Measuring Renuvion Soft Tissue Contraction Using Ultrasound
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