Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)

NCT06768073 | Not Yet Recruiting FDA Device

• 1 other identifier: 10510
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

This pilot study aims to evaluate the safety and effectiveness of the VITA AV Clinical System over a period of up to three months after the last treatment, compared to a sham device. The study focuses on improving vaginal signs and symptoms of Genitourinary Syndrome of Menopause (GSM) in post-menopausal women who experience moderate to severe pain during intercourse (dyspareunia). Long-term follow-up visits will assess the ongoing effectiveness and durability of the treatment, while also collecting safety data.

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (4)

• Safety Evaluation of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.

  Safety will be assessed by monitoring all adverse events, with particular attention to serious adverse events (SAEs) related to the device or procedure.

  Baseline to 3-months post the last treatment.

• Percentage of Vaginal Superficial Cells to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.

  Quantified using cytological analysis to determine the percentage of superficial cells. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.

  Baseline to 3-months post the last treatment.

• Vaginal Moisture Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.

  Measured using the modified Schirmer Test to assess changes in vaginal hydration levels. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.

  Baseline to 3-months post the last treatment.

• Vaginal pH Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.

  Measured by inserting a cotton swab vaginally, and applying it to the vaginal pH strip to determine changes in vaginal acidity. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.

  Baseline to 3-months post the last treatment.

Secondary Outcomes (6)

• Vaginal Health Index (VHI) changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.

  Baseline to 3-months post the last treatment.

• Vaginal Maturation Index (VMI) changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.

  Baseline to 3-months post the last treatment.

• Vaginal Mucosa Assessment (VMA) changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.

  Baseline to 3-months post the last treatment.

• Severity of GSM Symptoms changes from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.

  Baseline to 3-months post the last treatment.

• Durability of Benefit from baseline to each visit (treatment phase and up to the 3-month follow-up) for treatment with the VITA AV Clinical System compared to a sham device.

  Baseline to 3-months post the last treatment.

Other Outcomes (11)

• Long-term Safety Evaluation of the VITA AV Clinical System Treatment.

  Baseline to 12-months post the last treatment

• Percentage of Vaginal Superficial Cells to evaluate the Long-term Clinical Efficacy of the VITA AV Clinical System Treatment.

  Baseline to 12-months post the last treatment.

• Vaginal Moisture Levels to evaluate the Long-term Clinical Efficacy of the VITA AV Clinical System Treatment.

  Baseline to 12-months post the last treatment.

Study Arms (2)

Active Treatment

EXPERIMENTAL

The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a white connector component, part number 10531-01, to allow the vacuum to be delivered to the vaginal tissue when then vacuum pump is activated.

Device: Sham (No Treatment)

Sham Treatment

SHAM COMPARATOR

The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a black connector component, part number 10531-02, to block and prevent the vacuum from being delivered to the vaginal tissue when then vacuum pump is activated.

Device: Sham (No Treatment)

Interventions

Sham (No Treatment) DEVICE

The Sham device is identified to the Active device with the exception that it has a black connector component, part number 10531-02, to block the vacuum from reaching the vaginal tissue with vacuum pump activation. In this manner, the control procedure has been designed to mimic the active therapy to the extent practicable allowing for subject blinding.

Active Treatment; Sham Treatment

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cycle.
• Willingness to refrain from using alternative therapies for treatment of symptoms of GSM, unless medically necessary, through the duration of this study.
• Moderate to severe dyspareunia associated with GSM. (i.e., ≥4 on the 11-point patient-reported numeric rated dyspareunia scale).
• Subjects who are sexually active (i.e. have had or have attempted to have sexual activity with vaginal penetration within approximately 1 month of screening visit).
• Subjects who anticipate engaging or attempting to engage in sexual activity (with vaginal penetration) at least twice a month during the trial.
• Vaginal Health Index (VHI) score of less than or equal to 15.
• Vaginal pH \>5.0.
• The subject is anatomically suitable to the intravaginal tip as determined by the Investigator.
• Normal Papanicolaou test within the past year (or should be done 2 weeks before the trial begins). Subject can ONLY participate on negative results.
• Vaginal canal free of any lesions other than symptoms of GSM as determined by the Investigator.
• Negative screening for chlamydia, gonorrhea, bacterial vaginosis, trichomonas and yeast.
• Willingness and ability to give voluntary written informed consent to participate in the study and comply with protocol requirements.
• Willingness to refrain from sexual intercourse for at least 48 hours before all visits and for at least 48 hours after all treatments.
• Willingness to stop using current vaginal lubricant, moisturizers or similar and only use the lubricant provided by the clinic.
• Willingness to stop using the clinic assigned lubricant for at least 48 hours before all scheduled visits post screening.

You may not qualify if:

• Subjects with bleeding disorders.
• Subjects with any sexually transmitted disease.
• Subjects on prescribed anticoagulants such as antiplatelets and anticoagulants (Heparin, Warfarin, Clopidogrel, Apixaban, Rivaroxaban).
• Any active genital infections.
• Abnormal Papanicolaou test within the past year.
• Positive pregnancy test or planned pregnancy during the study period.
• Complete procidentia or prolapse that in investigator opinion would be unsuitable for probe placement.
• Subjects with urogenital sinus (this is when urethral opening is combined with the vagina opening), otherwise the urethral opening will be traumatized potentially resulting in a urinary tract infection (UTI).
• Subjects with a compromised immune system.
• Subjects who have undergone pelvic irradiation treatment.
• Subjects who have undergone off-label procedures such as "vaginal rejuvenation" (e.g., laser or thermoablative techniques).
• Pelvic surgery within 6 months prior to the start of the study.
• Undiagnosed vaginal bleeding.
• Subjects with bleeding during screening examination due to friable vaginal mucosa and/or very thin epithelial layer, such that investigator determines the VITA AV treatment would be contraindicated.
• Subjects receiving chemotherapy or radiotherapy or subjects with any diagnosed gynecological cancers.

Sponsors & Collaborators

• AVeta Medical: lead

Study Sites (2)

IMA Clinical Research,

Warren Township, New Jersey, 07059, United States

Location

Pineo Clinic (Pineo Medical Ecosystem)

Tbilisi, 0114, Georgia

Location

Study Officials

• Nancy Philips

  IMA Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orla O'Loughlin

CONTACT

+353 87 248 3582; orla@avetamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization with take place after successful screening of the subjects and prior to the first treatment. Also, to minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 10, 2025
• Study Start: March 3, 2025
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

US (1); GE (1)