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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VITA AV Clinical System | Experimental | VITA AV Clinical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VITA AV Clinical System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Follow-Up Visit at 1 month |
| 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'. | Lat Treatment |
| Primary Safety Endpoint #2: Serious Adverse Events (SAEs) | Assessment of Serious Adverse Events (SAEs) with emphasis on device or treatment related events. | Follow-Up Visit at 1 month |
| 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. | Follow-Up Visit at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
An increase in VMI score is expected. |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Safety Data (Trial Extension) | Evaluation of Adverse Events (serious and non-serious) at 12 months post final treatment | Follow-Up Visit at 12 month |
| Long Term Clinical Effect (Trial Extension) |
Inclusion Criteria:
Exclusion Criteria:
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).
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pineo Clinic (Pineo Medical Ecosystem) | Tbilisi | 0114 | Georgia |
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| Final Follow-Up Visit at 1 month |
| 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. | Final Follow-Up Visit at 1 month |
| 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:
An increase in VHI score is expected. | Follow-Up Visit at 1 month |
| 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. | Follow-Up Visit at 1 month |
| 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:
| Follow-Up Visit at 1 month |
Evaluation of the long-term clinical effect based on subjective evidence for symptom relief experienced as a result of the VITA AV Clinical System treatment, i.e., the severity rating of the MBS as indicated by the subject at the 10- and 12-month follow-up visits.
| Follow-Up Visit at 12 month |
| Long Term Durability (Trial Extension) | Durability of benefit of the VITA AV treatment is assessed based on the subjects' answers to the following question "From the final treatment, approximately how long did the benefit/improvement last?" which is gathered at the 10- and 12-month follow-up visits. | Follow-Up Visit at 12 month |