Clinical trial NCT06207227: Clinical Performance and Safety of the VITA AV Clinical System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Lead sponsor: AVeta Medical
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 12
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy postmenopausal women from 51 years up to and including 70 years.
2. 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).
3. Vaginal Health Index (VHI) score between 6-15, indicating mild to moderate VA.
4. 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.
5. 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.
6. Vaginal canal free of any lesions or abnormalities other than signs of VA.
7. Willing and able to sign an Informed Consent Form (ICF).
8. 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.
9. 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
10. 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.

Exclusion Criteria:

1. Vaginal Health Index (VHI) score of 5 or less (indicates severe VA).
2. Subjects on Hormone Replacement Therapies (HRT), systemic or local, or within 6 months of cessation of HRT prior to inclusion in the study.
3. 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.
4. Subjects with bleeding disorders.
5. Subjects on prescribed blood thinners such as antiplatelets and anticoagulants (Heparins, Warfarin or Clopidogrel).
6. Acute UTIs.
7. Any active genital infections.
8. Abnormal Pap smear test.
9. Positive pregnancy test or planned pregnancy during the study period.
10. Uterine prolapse.
11. 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.
12. Undergone pelvic surgery within 6 months prior to the start of the study.
13. Undiagnosed vaginal bleeding.
14. Cancer patients on chemotherapy or subjects with any diagnosed gynaecological cancers.
15. Breast cancer survivors who have had chemotherapy within the last 5 years or are on aromatase inhibitors.
16. Subjects where the one-size VITA AV intravaginal tip does not fit comfortably within the patient's vagina (in the clinician's opinion).
17. Any serious disease or chronic condition that could jeopardize the subject's ability to complete the trial assessments.
18. 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.
19. Subjects who do not have the mental or physical ability to comply with time schedules and further study procedures.
20. Subjects with urinary symptoms as their MBS will be excluded from the study due to other potential causes of this symptom.

Primary outcomes:
measure: Most Bothersome Symptom (MBS) Improvement from Baseline to 1-Month Follow-Up
timeFrame: Follow-Up Visit at 1 month
measure: Primary Safety Endpoint #1:The degree of pain experienced during each treatment session from the first to the last treatment.
timeFrame: Lat Treatment
measure: Primary Safety Endpoint #2: Serious Adverse Events (SAEs)
timeFrame: Follow-Up Visit at 1 month
measure: Primary Safety Endpoint #3: Serious Adverse Device Effects (SADEs) at each treatment and follow-up visit.
timeFrame: Follow-Up Visit at 1 month
Secondary outcomes:
measure: Vaginal Maturation Index (VMI) Improvement
timeFrame: Final Follow-Up Visit at 1 month
measure: Vaginal/urinal pH Improvement
timeFrame: Final Follow-Up Visit at 1 month
measure: Vaginal Health Index (VHI) Improvement
timeFrame: Follow-Up Visit at 1 month
measure: Improvement in visual appearance of the vaginal mucosa
timeFrame: Follow-Up Visit at 1 month
measure: Overall subject satisfaction with treatment after 3x treatment sessions at MTD at the final follow-up visit
timeFrame: Follow-Up Visit at 1 month
Other outcomes:
measure: Long Term Safety Data (Trial Extension)
timeFrame: Follow-Up Visit at 12 month
measure: Long Term Clinical Effect (Trial Extension)
timeFrame: Follow-Up Visit at 12 month
measure: Long Term Durability (Trial Extension)
timeFrame: Follow-Up Visit at 12 month
Locations:
city: Tbilisi
country: Georgia
facility: Pineo Clinic (Pineo Medical Ecosystem)
Study officials:
References: