Clinical Performance and Safety of the VITA AV Clinical System

NCT06207227 | Completed

• 1 other identifier: 10545
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Atrophy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Vaginal Maturation Index (VMI) Improvement

  Final Follow-Up Visit at 1 month

• Vaginal/urinal pH Improvement

  Final Follow-Up Visit at 1 month

• Vaginal Health Index (VHI) Improvement

  Follow-Up Visit at 1 month

• Improvement in visual appearance of the vaginal mucosa

  Follow-Up Visit at 1 month

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

  Follow-Up Visit at 1 month

Other Outcomes (3)

• Long Term Safety Data (Trial Extension)

  Follow-Up Visit at 12 month

• Long Term Clinical Effect (Trial Extension)

  Follow-Up Visit at 12 month

• Long Term Durability (Trial Extension)

  Follow-Up Visit at 12 month

Study Arms (1)

VITA AV Clinical System

EXPERIMENTAL

VITA AV Clinical System

Device: VITA AV Clinical System

Interventions

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.

VITA AV Clinical System

Eligibility Criteria

• Age: 51 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Vaginal Health Index (VHI) score of 5 or less (indicates severe VA).
• 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).

Sponsors & Collaborators

• AVeta Medical: lead

Study Sites (1)

Pineo Clinic (Pineo Medical Ecosystem)

Tbilisi, 0114, Georgia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 16, 2024
• Study Start: April 13, 2023
• Primary Completion: October 20, 2023
• Study Completion: September 25, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)