Vaginal Atrophy Clinical Trial
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
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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