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Clinical 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06207227
Study type Interventional
Source AVeta Medical
Contact
Status Completed
Phase N/A
Start date April 13, 2023
Completion date October 20, 2023

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