Retrospective Chart Review Study of Patients Treated With Votiva Device

Completed

Conditions studied: Vulvovaginal Signs and Symptoms

In brief

retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.

Key facts

Study ID

NCT04437680

Run by

InMode MD Ltd.

People needed

600

Starts

2020-06-05

Expected to finish

2020-12-30

Last updated by the study team

2022-01-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• age ≥ 18years of age at the time of the procedure
• patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness.
• At least one Votiva procedure that included FormaV applicator treatment with or without combination with Fractora/Morpheus8 Applicators treatments

You may not qualify if…

• active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.

Where it is running

• Advanced Women's Care of the Lowcountry — Hilton Head Island, South Carolina, United States
• Owen Health Group — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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