Intravaginal Device for Genitourinary Syndrome

Not yet recruiting at 2 trial locations

Overseen By Orla O'Loughlin

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: AVeta Medical

Must not be taking: Hormone therapies, Anticoagulants

Disqualifiers: Bleeding disorders, STDs, Genital infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the VITA AV Clinical System, to determine its safety and effectiveness in relieving symptoms of Genitourinary Syndrome of Menopause (GSM), with a focus on reducing pain during intercourse for post-menopausal women. Participants will use either the active treatment or a sham (inactive) version to compare results. Women experiencing moderate to severe pain during sex and who have not had a menstrual cycle for 1 to 15 years may be suitable candidates.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the quality of life for many women.

Will I have to stop taking my current medications?

The trial requires participants to stop using hormone therapies and certain anticoagulants (blood thinners) before joining. You also need to stop using your current vaginal lubricants and moisturizers during the study.

What prior data suggests that this intravaginal device is safe for post-menopausal women with Genitourinary Syndrome of Menopause?

Research has shown that the VITA AV Clinical System, used to treat menopause symptoms affecting the urinary and genital areas, has been tested for both safety and effectiveness. Although past studies provide limited safety information, ongoing research aims to understand how well people tolerate this treatment.

While specific side effects have not been listed, the study's focus on safety ensures that any potential side effects are monitored closely. As this is an early-stage study, detailed safety information may still be developing. Participants in clinical trials like this one are typically monitored closely for any side effects, allowing for quick response to any issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VITA AV Clinical System for treating genitourinary syndrome because it uses a novel delivery method involving an intravaginal device that applies a vacuum to the vaginal tissue. This approach is different from standard treatments like hormonal therapies and lubricants, which address symptoms but might not stimulate the same kind of tissue response. The vacuum technology aims to enhance tissue health and function by increasing blood flow, potentially offering a non-hormonal alternative that could be more suitable for individuals who cannot use or prefer to avoid hormone-based treatments.

What evidence suggests that the VITA AV Clinical System is effective for Genitourinary Syndrome of Menopause?

This trial will evaluate the VITA AV Clinical System for its effectiveness in improving symptoms of Genitourinary Syndrome of Menopause (GSM). Studies have shown that treatments like the VITA AV Clinical System can help improve GSM symptoms. Research indicates that 70% to 80% of participants were satisfied or very satisfied with similar treatments and did not experience any serious side effects. Low estrogen levels mainly cause GSM symptoms, and treatments aim to improve the condition by making the vaginal tissue healthier. Although researchers are still studying this system, using vacuum technology to stimulate the tissue might help relieve symptoms like pain during sex. Early findings suggest the VITA AV System could be promising for those with moderate to severe GSM symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Nancy Philips

Principal Investigator

IMA Clinical Research

Are You a Good Fit for This Trial?

This trial is for post-menopausal women with moderate to severe pain during intercourse due to Genitourinary Syndrome of Menopause (GSM). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

Inclusion Criteria

I plan to be sexually active at least twice a month during the trial.

I am willing to not use any clinic-provided lubricant for 48 hours before my visits.

Normal Papanicolaou test within the past year (or should be done 2 weeks before the trial begins). Subject can ONLY participate on negative results

Exclusion Criteria

Abnormal Papanicolaou test within the past year

I do not have any active genital infections.

Positive pregnancy test or planned pregnancy during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive the VITA AV Clinical System or sham device treatment over four sessions at 4-week intervals

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person), 1 visit (phone call)

Long-term Follow-up

Long-term follow-up visits to assess ongoing effectiveness and durability of the treatment

12 months

3 visits (in-person), 1 visit (phone call)

What Are the Treatments Tested in This Trial?

Interventions

• VITA AV Clinical System

Trial Overview The VITA AV Clinical System, a medical device designed to alleviate symptoms of GSM, is being tested against a sham (no treatment) device. The study will monitor the safety and effectiveness up to three months after the last treatment and include long-term follow-up visits.

How Is the Trial Designed?

Group I: Active Treatment Experimental Treatment 1 Intervention

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.

Group II: Sham Treatment Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

AVeta Medical

Lead Sponsor

Trials

2

Recruited

70+

Published Research Related to This Trial

The pilot study involving 85 women with severe vulvovaginal atrophy (VVA) showed that treatment with Vaginal Soft gels significantly improved sexual function and vaginal health, particularly in postmenopausal and recurrent vulvovaginitis patients.

The treatment was found to be effective without causing systemic or local side effects, making it a suitable option for patients who cannot use hormonal therapies, although results were less significant in postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of soft gel technology: a new vaginal device to improve the symptomatology of vulvovaginal atrophy in post-partum, menopause and in patients with recurrent vulvovaginitis. Maniglio, P., Ricciardi, E., Meli, F., et al.[2020]

A review of 42 medical device reports on vaginal energy-based devices revealed that most patient complaints, including vaginal pain and urinary symptoms, were not severe, with serious adverse events being rare (only 3.5% reported third-degree burns).

The majority of complaints were reported after the FDA's July 30, 2018 warning, suggesting that increased awareness and potential litigation may have influenced reporting rates, highlighting the need for further research on the safety and efficacy of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Wallace, SL., Sokol, ER., Enemchukwu, EA.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06768073

Study Details | NCT06768073 | Intravaginal Negative ... 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, ...

2. ctv.veeva.com ctv.veeva.com/study/clinical-performance-and-safety-of-the-vita-av-clinical-system

Clinical Performance and Safety of the VITA AV Clinical System The primary objective of this clinical investigation is to demonstrate that treatment with the VITA AV clinical system is feasible and to ...

3. monalisatouch.ch monalisatouch.ch/wp-content/uploads/V2LR_Paraiso_et_al_Menopause_Sep2019.eng_.pdf

A randomized clinical trial comparing vaginal laser therapy to ... Overall, 70% to 80% of participants were satisfied or very satisfied with either treatment and there were no serious adverse events. Key Words: Genitourinary ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12315567/

The Prevalence and Predictive Factors of Genitourinary ... Genitourinary Syndrome of Menopause (GSM) refers to signs and symptoms caused by estrogen deficiency in the genitourinary system.

5. mdpi.com mdpi.com/2039-7283/15/8/155

Efficacy of Non-Invasive Monopolar Radiofrequency for ... Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) represent significant, yet frequently underestimated, health concerns for aging women, ...

6. app.trialscreen.org app.trialscreen.org/trials/clinical-performance-safety-vita-av-system-trial-nct06207227

Clinical Performance and Safety of the VITA AV ... The primary objective of this clinical investigation is to demonstrate that treatment with the VITA AV clinical system is feasible and to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10744987/

CO2 Laser versus Sham Control for the Management of ... In conclusion, vaginal CO2 laser therapy emerges as a promising alternative for GSM management, especially for most bothersome GSM symptoms; ...

8. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06207227?keyword=%22Vaginal%20Atrophy%22

Clinical Performance and Safety of the VITA AV ... After recruitment of the subject, the initial assessment of the enrolled patient will be performed, which includes screening, baseline evaluations ...