Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure with the Renuvion APR System in the labia | Other | The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renuvion APR System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days and 180-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the labia. Change was assessed as success with success being the correct identification of treated labia images by at least 2 of the 3 reviewers. | Day 90, Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Morphometric Labia Measurements at D180. | Analysis by anatomical measurements of the labia majora and minora at D180. | Day 180 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul G Ruff, MD | West End Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allison Plastic Martinez | Washington D.C. | District of Columbia | 20037 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
There were no pre-assignments, but 7 subjects were treated with the APR-15-TP Handpiece and 3 of the subjects were treated with the Micro Handpiece launched after the study began.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Procedure With the Renuvion APR System in the Labia (APR-15-TP) | The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group. Renuvion APR System: 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. |
| FG001 | Procedure With the Renuvion APR System in the Labia (Micro) | The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group. Renuvion APR System: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Procedure With the Renuvion APR System in the Labia | The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. |
| BG001 | Procedure With the Renuvion Micro System in the Labia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days and 180-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the labia. Change was assessed as success with success being the correct identification of treated labia images by at least 2 of the 3 reviewers. | Posted | Count of Units | Sets of B/A Images analyzed | Day 90, Day 180 | Sets of B/A Images analyzed | Sets of B/A Images analyzed |
|
180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Procedure With the Renuvion APR System in the Labia (APR-15-TP) | The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group. Renuvion APR System: 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crepitus (ETE) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul G. Ruff, MD | West End Plastic Surgery | 202-785-4187 | drruff@westendplasticsurgery.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2023 | Nov 27, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
MOTAKEF scale of labia protrusion, Type I-A: Less than 2cm, Type II-A: From 2cm to 4cm, Type II-C: From 2cm to 4cm, Type II-AI: From 4cm to 6 cm, Type VI-A: Greater than 6 cm. The greater the class the greater area of protrusion of labia minora past the labia majora. An "A" is added for asymmetry and a "C" for involvement of the clitoral hood. |
| Day 30, Day 90, Day 180 |
| Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) 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 lower the type the better the outcome. | Day 30, Day 90, Day 180 |
| The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | The subjects completed a Patient Satisfaction Questionnaire (PSQ) at the Day 180 follow-up visit. The subject completed this assessment while referring to baseline photos, current photos, and a hand mirror. | Day 180 |
| During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | During study treatment, the subject's pain levels were monitored using the 11-point Numeric Rating Scale (NRS). The average pain score for the entire region treated was recorded. Pain scores will be recorded at all follow-up visits. NRS 11-point Scale where 0 is no pain and 10 is most pain. | Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180 |
| The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area. | The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, completed a bilateral GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Day 30, Day 90, Day 180 |
| The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | The subject completed a GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Day 30, Day 90, Day 180 |
| The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | Female Sexual Function Index (FSFI) evaluation which measures desire, arousal, lubrication, orgasm, satisfaction, and pain, was administered at baseline, Day 90, and Day 180; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula. Response options for questions were: 0=no sexual activity, 5=almost always or always, 4=most times (more than half the time), 3=sometimes (about half the time), 2=a few times (less than half the time), 1=almost never or never. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the specified domain factor. The full-scale score is obtained by adding the six domain scores with potential ranges from 2 to 36. | Baseline, Day 90, Day 180 |
| The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | The Genital Appearance Satisfaction (GAS) scale was used to assess the satisfaction of subjects with their genital appearance following treatment to the labia at baseline, Day 90, and Day 180. The higher the GAS score reveals the greater dissatisfaction. Response options for each section of questions were Never (score 3), Sometimes (score 2), Often (score 1), Always (score 0). Question response values were added together for a final score for each participant. The best response would be 0 (no dissatisfaction). The worse response would be 30 (dissatisfaction across all questions). | Baseline, Day 90, Day 180 |
| Analysis of Days Until Subject Was Comfortable Returning to Sex. | Subjects report the number of days until they feel comfortable returning to sex. | Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180 |
The labia procedure utilizing the Renuvion Micro system will be performed per the investigator's standard clinical practice. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Full Range | kg/m2 |
|
| OG001 | Procedure with the Renuvion APR System in the labia (Micro) | The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group. Renuvion APR System: 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. |
|
|
| Secondary | Analysis of Morphometric Labia Measurements at D180. | Analysis by anatomical measurements of the labia majora and minora at D180. | Posted | Median | Standard Deviation | cm | Day 180 |
|
|
|
| Secondary | 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, Type I-A: Less than 2cm, Type II-A: From 2cm to 4cm, Type II-C: From 2cm to 4cm, Type II-AI: From 4cm to 6 cm, Type VI-A: Greater than 6 cm. The greater the class the greater area of protrusion of labia minora past the labia majora. An "A" is added for asymmetry and a "C" for involvement of the clitoral hood. | Posted | Count of Participants | Participants | Day 30, Day 90, Day 180 |
|
|
|
| Secondary | Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) 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 lower the type the better the outcome. | Posted | Count of Participants | Participants | Day 30, Day 90, Day 180 |
|
|
|
| Secondary | The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit. | The subjects completed a Patient Satisfaction Questionnaire (PSQ) at the Day 180 follow-up visit. The subject completed this assessment while referring to baseline photos, current photos, and a hand mirror. | Posted | Number | participants | Day 180 |
|
|
|
| Secondary | During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS). | During study treatment, the subject's pain levels were monitored using the 11-point Numeric Rating Scale (NRS). The average pain score for the entire region treated was recorded. Pain scores will be recorded at all follow-up visits. NRS 11-point Scale where 0 is no pain and 10 is most pain. | Posted | Median | Standard Deviation | Score on a Scale | Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180 |
|
|
|
| Secondary | The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area. | The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, completed a bilateral GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Posted | Count of Participants | Participants | Day 30, Day 90, Day 180 |
|
|
|
| Secondary | The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area. | The subject completed a GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse | Posted | Count of Participants | Participants | Day 30, Day 90, Day 180 |
|
|
|
| Secondary | The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia. | Female Sexual Function Index (FSFI) evaluation which measures desire, arousal, lubrication, orgasm, satisfaction, and pain, was administered at baseline, Day 90, and Day 180; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula. Response options for questions were: 0=no sexual activity, 5=almost always or always, 4=most times (more than half the time), 3=sometimes (about half the time), 2=a few times (less than half the time), 1=almost never or never. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the specified domain factor. The full-scale score is obtained by adding the six domain scores with potential ranges from 2 to 36. | Posted | Median | Standard Deviation | Score on FSFI Scale (Range 2 - 36) | Baseline, Day 90, Day 180 |
|
|
|
| Secondary | The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits | The Genital Appearance Satisfaction (GAS) scale was used to assess the satisfaction of subjects with their genital appearance following treatment to the labia at baseline, Day 90, and Day 180. The higher the GAS score reveals the greater dissatisfaction. Response options for each section of questions were Never (score 3), Sometimes (score 2), Often (score 1), Always (score 0). Question response values were added together for a final score for each participant. The best response would be 0 (no dissatisfaction). The worse response would be 30 (dissatisfaction across all questions). | Posted | Mean | Standard Deviation | Score on GAS Scale (0 -30 Range) | Baseline, Day 90, Day 180 |
|
|
|
| Secondary | Analysis of Days Until Subject Was Comfortable Returning to Sex. | Subjects report the number of days until they feel comfortable returning to sex. | Posted | Median | Standard Deviation | Days | Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | Procedure With the Renuvion APR System in the Labia (Micro) | The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group. Renuvion APR System: 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. | 0 | 3 | 0 | 3 | 3 | 3 |
| Bruise (ETE) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Edema (ETE) | Surgical and medical procedures | Non-systematic Assessment |
|
| Hypoesthesia/Numbness (ETE) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pain/Tenderness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus/Itching (ETE) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Wound | Surgical and medical procedures | Non-systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Hematoma |
|
There is an agreement between the Principal Investigator and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed. The data produced by this sponsored study is the sole property of Sponsor. Sponsor must be provided with the opportunity to review all Investigator-prepared abstracts, publications, or presentations for a period of thirty (30) days for presentational materials and abstracts and forty-five (45) days for manuscripts.
| Posterior Border of the Sulcus to the Fornix Day 180 |
|
| Inter-Labial Sulcus Length Day 180 |
|
| Resting Projection of Labia Minora Beyond Labia Majora Day 180 |
|
| Maximum Projection of the Labia Minora Day 180 |
|
| Maximum Projection of Labia Majora Day 180 |
|
| Arch of Labia Minora Day 180 |
|
| Arch of Labia Majora Day 180 |
|
| Type II-C: From 2cm to 4cm |
|
| Type II-AI: From 4cm to 6 cm |
|
| Type VI-A: Greater than 6 cm |
|
| Day 30 |
|
| Day 90 |
|
| Day 180 |
|
| Type III: From 4cm to 6 cm |
|
| Type VI: Greater than 6 cm |
|
| Day 30 |
|
| Day 90 |
|
| Day 180 |
|
| Recommend Procedure To Friends and Family Members - Yes |
|
| Improvement noticed - Closer together |
|
| Improvement noticed - Improvement in loose skin |
|
| Improvement noticed - Less sagging skin |
|
| Improvement noticed - Majora seem smaller-Right Minora seems same or only slight improvement |
|
| Improvement noticed - Smoother skin texture |
|
| Day 14 |
|
| Day 30 |
|
| Day 90 |
|
| Day 180 |
|
| Improved, Much Improved, Very Much Improved |
|
| Day 90 |
|
| Day 180 |
|
| Improved, Much Improved, Very Much Improved |
|
| Day 90 |
|
| Day 180 |
|
| FSFI Day 180 |
|
| Genital Appearance Satisfaction Day 180 |
|