NCT06207227

Clinical Performance and Safety of the VITA AV Clinical System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: AVeta Medical · Academic / Other
• Sex: Female
• Age: 51 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DEVICE	VITA AV Clinical System	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.

Timeline

• Start date: 2023-04-13
• Primary completion: 2023-10-20
• Completion: 2024-09-25
• First posted: 2024-01-16
• Last updated: 2024-12-17

Locations

1 site across 1 country: Georgia