Status:
COMPLETED
Retrospective Chart Review Study of Patients Treated With Votiva Device
Lead Sponsor:
InMode MD Ltd.
Conditions:
Vulvovaginal Signs and Symptoms
Eligibility:
FEMALE
18+ years
Brief Summary
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.
Eligibility Criteria
Inclusion
- 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
Exclusion
- active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.
Key Trial Info
Start Date :
June 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04437680
Start Date
June 5 2020
End Date
December 30 2020
Last Update
January 11 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Women's Care of the Lowcountry
Hilton Head Island, South Carolina, United States, 29926
2
Owen Health Group
Lubbock, Texas, United States, 79424