Back to resultsEvaluation of the Use of the Renuvion APR System in the Labia
Primary Purpose
Labia Enlarged, Labium; Hypertrophy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renuvion APR System
Sponsored by
About this trial
This is an interventional treatment trial for Labia Enlarged
Eligibility Criteria
Inclusion Criteria:
- Female subjects, ages 35 - 70 years old.
- ASA Physical Status Classification System Class I and Class II subjects.
- Labial protrusion Class II and Class III (MOTAKEF scale)12.
- Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
- Absence of physical conditions unacceptable to the investigator.
- Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
- Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
- Willing to release rights for the use of study photos, including in publication.
- Able to read, understand, sign, and date the informed consent.
Exclusion Criteria:
- Labial protrusion Class I (MOTAKEF scale).
- Subjects presenting with ASA Physical Status Classification System Classes III or higher.
- Pregnant, lactating, or plans to become pregnant during study participation.
- Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
- Previous treatment in the study treatment area.
- Active systemic or local skin disease that may alter wound healing.
- Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
- Known susceptibility to keloid formation or hypertrophic scarring.
- Cancerous or pre-cancerous lesions in the area to be treated.
- Possesses a surgically implanted electronic device (i.e., pacemaker).
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- Participation in any other investigational study within 30 days prior to consent and throughout study participation.
- Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Sites / Locations
- Allison Plastic MartinezRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Procedure with the Renuvion APR System in the labia
Arm Description
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.
Outcomes
Primary Outcome Measures
Evaluation of change between baseline and follow-up images as determined by a masked, qualitative assessment of photographs at 90-days and 180-days post-treatment compared to baseline.
Correct selection of post-treatment images by independent photographic reviewers.
Analysis of adverse events through the 180-day post-treatment visit.
Analysis of adverse events
Secondary Outcome Measures
Analysis of morphometric labia measurements at baseline, D30, D90, and D180.
Measurement of labia, cm
Analysis of labia protrusion (distance of the lateral edge of the labia minora from that of the labia majora rather than the introitus) at baseline, D30, D90, and D180.
MOTAKEF scale of labia protrusion, Class I (0 to 2cm of protrusion), Class II (2 to 4cm), Class III (>4cm).
Analysis of hypertrophy of the labia minora (Hipertrofia de Ninfas13) at baseline, D30, D90, and D180
Hipertrofia de Ninfas scale of hypertrophy; Type I (Less than 2cm), Type II (2-4cm), Type III (4-6cm), Type IV (<6cm)
The subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 180-day follow-up visits.
Satisfaction Questions
During study treatment, the subject's pain levels will be monitored using the 11-point Numeric Rating Scale (NRS)21. The average pain score for the entire region treated will be recorded. Pain scores will be recorded at all follow-up visits
11-point Scale where 0 is no pain and 10 is most pain.
The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment
Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
The subject will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment
Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
The subject will complete a Female Sexual Function Index (FSFI)16 at the Baseline, 90, and 180-day follow-up visits
Female Sexual Function Index (FSFI)16 evaluation; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula.
The subject will complete a Genital Appearance Satisfaction (GAS)20 scale at baseline, 90, and 180-day follow-up visits
Genital Appearance Satisfaction (GAS)20 scale; Never, Sometimes, Often, Always responses.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323630
Brief Title
Evaluation of the Use of the Renuvion APR System in the Labia
Official Title
Evaluation of the Use of the Renuvion APR System in the Labia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Labiaplasty is a procedure aimed at reducing lax or loose skin in the labia majora and/or minora due to childbirth, trauma, aging, genetics, or congenital disease.
Detailed Description
While traditional surgical procedures have been associated with complications such as dehiscence, hematoma, flap necrosis, narrowed introitus, and pain and asymmetry, correction with RF energy has shown minimal complication rates with high patient satisfaction. This study aims to evaluate the use of the Renuvion APR System for use as a minimally invasive alternative to surgical labiaplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labia Enlarged, Labium; Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, single-center, single arm, evaluator-blinded study of the subjects undergoing a procedure with the Renuvion APR System in the labia. Follow-up visits will occur 1D Contact, 14D, 30D, 90D, and 180D post-procedure. Images will be captured at baseline and all follow-up visits.
Three experienced, independent blinded photographic reviewers will perform a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images will be provided in a blinded and randomized order. Each blinded reviewer will choose which is the before image and which is the after. Success will be correct identification of before and after by at least 2 of the 3 reviewers.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Procedure with the Renuvion APR System in the labia
Arm Type
Other
Arm Description
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.
Intervention Type
Device
Intervention Name(s)
Renuvion APR System
Intervention Description
The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
Primary Outcome Measure Information:
Title
Evaluation of change between baseline and follow-up images as determined by a masked, qualitative assessment of photographs at 90-days and 180-days post-treatment compared to baseline.
Description
Correct selection of post-treatment images by independent photographic reviewers.
Time Frame
Day 90, 180
Title
Analysis of adverse events through the 180-day post-treatment visit.
Description
Analysis of adverse events
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
Analysis of morphometric labia measurements at baseline, D30, D90, and D180.
Description
Measurement of labia, cm
Time Frame
Day 30, 90, 180
Title
Analysis of labia protrusion (distance of the lateral edge of the labia minora from that of the labia majora rather than the introitus) at baseline, D30, D90, and D180.
Description
MOTAKEF scale of labia protrusion, Class I (0 to 2cm of protrusion), Class II (2 to 4cm), Class III (>4cm).
Time Frame
Day 30, 90, 180
Title
Analysis of hypertrophy of the labia minora (Hipertrofia de Ninfas13) at baseline, D30, D90, and D180
Description
Hipertrofia de Ninfas scale of hypertrophy; Type I (Less than 2cm), Type II (2-4cm), Type III (4-6cm), Type IV (<6cm)
Time Frame
Day 30, 90, 180
Title
The subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 180-day follow-up visits.
Description
Satisfaction Questions
Time Frame
Day 180
Title
During study treatment, the subject's pain levels will be monitored using the 11-point Numeric Rating Scale (NRS)21. The average pain score for the entire region treated will be recorded. Pain scores will be recorded at all follow-up visits
Description
11-point Scale where 0 is no pain and 10 is most pain.
Time Frame
Post-Treatment, Day 1, 30, 90, 180
Title
The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment
Description
Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame
Day 30, 90, 180
Title
The subject will complete a bilateral GAIS19 assessing overall aesthetic improvement in the treatment area at day 30, 90, and 180 post-treatment
Description
Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame
Day 30, 90, 180
Title
The subject will complete a Female Sexual Function Index (FSFI)16 at the Baseline, 90, and 180-day follow-up visits
Description
Female Sexual Function Index (FSFI)16 evaluation; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula.
Time Frame
Baseline, Day 90, 180
Title
The subject will complete a Genital Appearance Satisfaction (GAS)20 scale at baseline, 90, and 180-day follow-up visits
Description
Genital Appearance Satisfaction (GAS)20 scale; Never, Sometimes, Often, Always responses.
Time Frame
Baseline, Day 90, 180
Other Pre-specified Outcome Measures:
Title
• Analysis of pre- and post-treatment genital (right and left labia majora and minora) vibratory perception measurements utilizing a biothesiometer. Readings may be conducted at each follow-up visit until measurements have returned to baseline.
Description
Vibratory perception measurements utilizing a biothesiometer
Time Frame
Baseline, Day 30, 90, 180
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female subjects, ages 35 - 70 years old.
ASA Physical Status Classification System Class I and Class II subjects.
Labial protrusion Class II and Class III (MOTAKEF scale)12.
Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
Absence of physical conditions unacceptable to the investigator.
Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
Willing to release rights for the use of study photos, including in publication.
Able to read, understand, sign, and date the informed consent.
Exclusion Criteria:
Labial protrusion Class I (MOTAKEF scale).
Subjects presenting with ASA Physical Status Classification System Classes III or higher.
Pregnant, lactating, or plans to become pregnant during study participation.
Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
Previous treatment in the study treatment area.
Active systemic or local skin disease that may alter wound healing.
Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
Known susceptibility to keloid formation or hypertrophic scarring.
Cancerous or pre-cancerous lesions in the area to be treated.
Possesses a surgically implanted electronic device (i.e., pacemaker).
Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
Participation in any other investigational study within 30 days prior to consent and throughout study participation.
Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kari A Larson, MBA
Phone
8012440058
Email
kari.larson@apyxmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G Ruff, MD
Organizational Affiliation
West End Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allison Plastic Martinez
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison P Martinez
Phone
202-785-4187
Email
allison@westendplasticsurgery.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Use of the Renuvion APR System in the Labia
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