RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity

May 31, 2023 updated by: Venus Concept

Multi-Polar RF and PEMF Technologies for the Treatment of Vaginal Laxity and for Treatment of the Mons Pubis and Labia for Improvement of Skin Laxity: 12-Month Safety and Efficacy

Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. The study will enroll up to 50 subjects who completed the Venus Fiore CS0716 study for the treatment of vaginal laxity and treatment of the mons pubis and labia for improvement in skin laxity. Subjects will be followed up at least six and twelve months post-treatment. Analysis will be performed on all subjects who complete the six-month and twelve month follow-up visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Traditional non-surgical treatments to treat vaginal laxity include Kegel exercises or pelvic floor therapy with electrical stimulation of the vaginal musculature to promote muscle strength. Although surgery to tighten the vaginal introitus has been used, pain at the incision site leading to dyspareunia, sometimes for months, limits its use. Surgery is also recommended to reduce protuberant mons pubis and the outer labial lips of the labia majora. Most often, the mons pubis has been treated by fat reduction, either by liposuction or open excision along with a pubic skin lift. Surgery to reduce the excess skin of the labia majora tends to be avoided due to a lack of operative techniques and a fear of creating sexual dysfunction. Development of alternative methods of treatment, avoiding the usual surgical complications is warranted.

The use of non-ablative radiofrequency (RF) therapy has been used previously for the external and internal female genitalia without incident or complications. The use of Multi-Polar RF and PEMF technology was already demonstrated to be safe and efficient in delivering heat to the tissue. A previous study investigated the safety and efficacy of combining these technologies for the treatment of vaginal laxity and in the treatment of the mons pubis and labia for the improvement in skin laxity at four-months post-treatment. Efficacy and safety was confirmed up to 4-months post-treatment. (Venus FioreTM CS0716 study, unpublished raw data). However, the durability of the treatment is not known.

This study will investigate whether Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia is safe and efficacious at six-months and twelve-months post-treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, L6B 0T1
        • Dr. George Arnold

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects who have completed at least two treatments in the Venus Fiore™ CS0716 study and are at least 6 months post Fiore™ treatment.
  2. Able to read, understand and voluntarily provide written Informed Consent.
  3. Able and willing to comply with the treatment/follow-up schedule and requirements.
  4. Sexual active and in a monogamous relationship

Exclusion Criteria:

  1. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
  2. Having a permanent implant in the treatment area.
  3. Prior use of collagen, fat injections and/or other methods of skin augmentation (enhancement with injected or implanted material) in the treatment areaduring the course of the study.
  4. Use of retinoids such as oral Isotretinoin (Accutane®) during the course of the study.
  5. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.
  6. Open laceration, abrasion or bleeding of any sort on the areas to be treated.
  7. Active sexual transmitted disease (STD) (e.g. genital Herpes Simplex, condylomata) or vaginosis.
  8. Chronic vulvar pain or vulvar dystrophy.
  9. Use of immunosuppressive medications, including corticosteroids, during the course of the study.
  10. Having any form of active cancer at the time of enrollment and during the course of the study.
  11. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the study, or healing process.
  12. Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.
  13. Evidence of active substance or alcohol abuse.
  14. Having any stage 3-4 cystocele, rectocele, enterocele paravaginal defect or major pelvic organ prolapse beyond the hymenal ring.
  15. Unstable dosages of medications such as antihypertensives or use of psychotropics that are known to affect sexuality.
  16. Skin piercing in the treatment area.
  17. Tattoos in the treatment area.
  18. Prior procedure in the treatment area with laser or other device during the course of the study.
  19. Use of an intrauterine device during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vulvovaginal Treatment

At visit 1 -(6 months post treatment in the CS0716 study):

AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional),

At Visit 2 (6 months post treatment in the CS0716 study):

AE assessment, VLQ, FSFI, GRAS and GAIS (optional), Vaginal pH and vaginal smear (optional), Administer study treatment (optional: internal, mons pubis and/or labia treatment).

Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)

Final AE follow-up 30 days post Visit 2 Treatment (if applicable): AE assessment (applicable only if treatment provided at Visit 2 in the FE1019 study).
Device: Vulvovaginal Treatment

Device model(s) - Venus Fiore™ Device settings and programming internal applicator - 42°C - 45°C Temperature output via automatic temperature control (ATC) (optional treatment).

Duration of exposure and frequency of exposure with internal applicator - one treatment for 12-15 minutes at 12 months (optional treatment).

Device settings and programming external mons pubis and labia applicators - 10-35% output (optional treatment).

Duration of exposure and frequency of exposure external applicators - one treament for 15 minutes for the mons pubis, 10 minutes for labia at 12 months (optional treatment).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Long term safety (Follow-up for any AEs) of the Venus Fiore Fiore™ (MP)2 system in vaginal laxity and skin laxity of the mons pubis and labia.
Time Frame: 6 months
AE assessment VLQ, FSFI, GRAS and GAIS (optional) Vaginal pH and vaginal smear (optional) Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
long term safety of the Venus Fiore Fiore™ (MP)2 system in improving vaginal laxity and skin laxity of the mons pubis and labia.
Time Frame: 12 months
AE assessment VLQ, FSFI, GRAS and GAIS (optional) Vaginal pH and vaginal smear (optional) Administer study treatment (optional: internal, mons pubis and/or labia treatment) Discomfort/pain 10 cm VAS, immediate response assessment (applicable only if treatment provided)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Venus Concept

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mathew Gronski, Venus Concept

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FE1019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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