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Vaginal AtrophyNCT06207227

Clinical Performance and Safety of the VITA AV Clinical System

A study testing VITA AV Clinical System in people with Vaginal Atrophy, run by AVeta Medical at 1 site in Georgia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this clinical investigation is to demonstrate that treatment with the VITA AV clinical system is feasible and to evaluate clinical performance and safety when used to improve the symptoms and signs of vaginal atrophy (VA) due to menopause. Read more about this study

Who is it for?
Ages 51 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Vaginal Atrophy
What is being tested?
VITA AV Clinical System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteGeorgia
Study dates
13 Apr 2023to 25 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 51 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy postmenopausal women from 51 years up to and including 70 years.
  • The subject must be able to identify an MBS of at least moderate severity from one of the following: vaginal dryness, itching, discharge, and dyspareunia (pain during intercourse).
  • Vaginal Health Index (VHI) score between 6-15, indicating mild to moderate VA.
  • The one-size intravaginal tip "VITA AV probe Kit" fits comfortably within the subject's vagina. Clinician to size the vagina using the vaginal dilator sizing kit and record the size on the assessment/record sheet. (25mm diameter, 60mm length). Urethral opening is distal to device sealing collar.
  • Normal Papanicolaou test within the past year (or should be done before the trial begins or 2 weeks before F1). Subject can ONLY participate on negative results.
  • Vaginal canal free of any lesions or abnormalities other than signs of VA.
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  • Willing and able to sign an Informed Consent Form (ICF).
  • Subjects must be willing to refrain from sexual intercourse for 48 hours before initial assessment, for 48 hours before and after each session [Familiarisation (F) and Treatment (T)] and for 48 hours before final follow-up visit.
  • Subjects must be willing to stop using any lubricant at least 48hrs before initial assessment (as if they use lubricant, it will affect sizing)before and after each session [Familiarisation (F) and Treatment (T)] and for 48 hours before final follow-up visit. Only use lubricant provided by the clinic to aid sexual intercourse
  • Subjects must be willing to discontinue/stop dilator/pelvic floor therapy 7 days before initial assessment and this therapy should not continue if the patient is participating in trial.

Who cannot join

  • Vaginal Health Index (VHI) score of 5 or less (indicates severe VA).
  • Subjects on Hormone Replacement Therapies (HRT), systemic or local, or within 6 months of cessation of HRT prior to inclusion in the study.
  • Use of vaginal moisturisers, or any other local vaginal preparation within 3 months prior to study inclusion.
  • Note: The use of simple non-moisturising lubricants to aid sexual intercourse can be accepted in the study.
  • Subjects with bleeding disorders.
  • Subjects on prescribed blood thinners such as antiplatelets and anticoagulants (Heparins, Warfarin or Clopidogrel).
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  • Acute UTIs.
  • Any active genital infections.
  • Abnormal Pap smear test.
  • Positive pregnancy test or planned pregnancy during the study period.
  • Uterine prolapse.
  • Subjects with urogenital sinus (this is when urethral opening is combined with the vagina opening), otherwise the urethral opening will be traumatized resulting in an UTI.
  • Undergone pelvic surgery within 6 months prior to the start of the study.
  • Undiagnosed vaginal bleeding.
  • Cancer patients on chemotherapy or subjects with any diagnosed gynaecological cancers.
  • Breast cancer survivors who have had chemotherapy within the last 5 years or are on aromatase inhibitors.
  • Subjects where the one-size VITA AV intravaginal tip does not fit comfortably within the patient's vagina (in the clinician's opinion).
  • Any serious disease or chronic condition that could jeopardize the subject's ability to complete the trial assessments.
  • Subjects who, in the opinion of the investigator, will be inappropriate for inclusion in this study or will not comply with the requirements of the study.
  • Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures.
  • Subjects with urinary symptoms as their MBS will be excluded from the study due to other potential causes of this symptom.

Trial locations and contacts

1 site in 1 country.

Georgia1 site

  • Pineo Clinic (Pineo Medical Ecosystem)

    Tbilisi, 0114

Other trials in Georgia

About this study

Official title: A Feasibility Study to Evaluate the Clinical Performance and Safety of the VITA AV Clinical System When Used for the Treatment of Vaginal Atrophy

The primary objective of this clinical investigation is to demonstrate that treatment with the VITA AV clinical system is feasible and to evaluate clinical performance and safety when used to improve the symptoms and signs of vaginal atrophy (VA) due to menopause.

Read the detailed description

After recruitment of the subject, the initial assessment of the enrolled patient will be performed, which includes screening, baseline evaluations \& pre-procedural assessments, suitability of device size for each patient (vaginal dilator kit- for sizing and recording) and endoscopic images will be done by the clinician.

Subjects will be introduced to the therapy over a 2-4week familiarisation period to determine their dosage. Subsequently, subjects will receive 3x treatment sessions over a 12-week window with a final follow-up 4 weeks after the final treatment session.

Conditions
Vaginal Atrophy
Being tested
VITA AV Clinical System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VITA AV Clinical SystemDevice

    The VITA AV Clinical System that works on the principle of negative pressure suction to the vaginal wall to treat VA, based on the idea of the clinical application in wound healing which is intended to elicit improvements in the rate of angiogenesis, moisture and HA production post-treatment. It is believed that the VITA AV Clinical System will provide a more effective treatment by improving the underlying cellular deficiencies associated with VA.

Study groups in NCT06207227
Study groupRoleWhat they receive
VITA AV Clinical SystemExperimentalVITA AV Clinical System
Receives: Device: VITA AV Clinical System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Most Bothersome Symptom (MBS) Improvement from Baseline to 1-Month Follow-Up

    To demonstrate that treatment with the VITA AV Clinical System improves the Most Bothersome Symptom (MBS) of VA in more than 50% of subjects after 3 treatment sessions at MTD.

    The MBS is selected from a list of symptoms (including vaginal dryness, itching, discharge, and dyspareunia (pain during intercourse)) and the subject must select a single symptom (among those classified as moderate to severe) as the MBS.

    MBS assessment (using a severity rating of no symptom, mild, moderate, severe) will be completed at baseline and immediately before each treatment session and 4 weeks after the last session during the follow-up phase. The change in the severity of the MBS from baseline to the 4-weeks after the last treatment is the evaluation for symptomatic improvement.

    Measured: Follow-Up Visit at 1 month

  2. Primary Safety Endpoint #1:The degree of pain experienced during each treatment session from the first to the last treatment.

    The degree of pain experienced during each treatment session will be assessed by using visual analogue scale (VAS), where the left extreme indicates 'no pain or discomfort', and the right extreme indicates 'severe pain or discomfort'.

    Measured: Lat Treatment

  3. Primary Safety Endpoint #2: Serious Adverse Events (SAEs)

    Assessment of Serious Adverse Events (SAEs) with emphasis on device or treatment related events.

    Measured: Follow-Up Visit at 1 month

  4. Primary Safety Endpoint #3: Serious Adverse Device Effects (SADEs) at each treatment and follow-up visit.

    Serious Adverse Device Effects (SADEs) with emphasis on device or treatment related events.

    Measured: Follow-Up Visit at 1 month

Secondary outcomes (5)

  1. Vaginal Maturation Index (VMI) Improvement

    Percent improvement in Vaginal Maturation Index (VMI) from the initial assessment visit to the final follow-up visit/session is calculated at 4 weeks after the last treatment and at the final follow-up visit.

    VMI Score is assigned as follows:

    1. ☐ 65% - 100% (premenopausal women with estrogenic environment).
    2. ☐ 50% - 64% (Moderate zero estrogenic effects on cells).
    3. ☐ ≤ 49% (zero estrogenic effects on cells).

    An increase in VMI score is expected.

    Measured: Final Follow-Up Visit at 1 month

  2. Vaginal/urinal pH Improvement

    Improvement in vaginal/urinal pH from the initial assessment visit to after 3x treatment sessions at MTD and at the final follow-up visit.

    Measured: Final Follow-Up Visit at 1 month

  3. Vaginal Health Index (VHI) Improvement

    Percent improvement in the Vaginal Health Index score (VHI) from the initial assessment visit to after 3x treatment sessions at MTD and at the final follow-up visit.

    VHI score is assigned as follows:

    1. ☐ 6 - 8.
    2. ☐ 9 - 12.
    3. ☐ 13 - 15.
    4. ☐ MORE THAN 15.

    An increase in VHI score is expected.

    Measured: Follow-Up Visit at 1 month

  4. Improvement in visual appearance of the vaginal mucosa

    Improvement in visual appearance of the vaginal mucosa (as assessed by endoscopic images) from the initial assessment visit to 4 weeks after the last treatment has been delivered.

    Measured: Follow-Up Visit at 1 month

  5. Overall subject satisfaction with treatment after 3x treatment sessions at MTD at the final follow-up visit

    Overall subject satisfaction with treatment after 3x treatment sessions at MTD at the final follow-up visit. The subject answers the following question 'Taking into account changes in VA symptoms, in overall well-being and quality of life, and any adverse events experienced, how would you define your level of satisfaction with the treatment and the device?'

    Overall subject satisfaction is subjective based on the subject's experience and is assigned the following rating:

    1. ☐ POOR
    2. ☐ FAIR
    3. ☐ GOOD
    4. ☐ VERY GOOD
    5. ☐ EXCELLENT

    Measured: Follow-Up Visit at 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start13 Apr 2023
  3. Primary completion20 Oct 2023
  4. Study completion25 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06207227
Sponsor's protocol ID
10545
Status last verified
Dec 2024
First submitted
13 Dec 2023
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VITA AV Clinical System in people with Vaginal Atrophy, run by AVeta Medical at 1 site in Georgia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Most Bothersome Symptom (MBS) Improvement from Baseline to 1-Month Follow-Up (time frame: Follow-Up Visit at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06207227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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