Retrospective Chart Review Study of Patients Treated With Votiva Device

NCT04437680 — Completed, 600 participants, InMode MD Ltd.

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Registry	NCT04437680
Status	Completed
Study type	Observational
Enrollment	600 (Actual)
Sponsor	InMode MD Ltd. (Industry)
Conditions	Vulvovaginal Signs and Symptoms
Interventions	Votiva device (Device)
Dates	start 2020-06-05, primary completion 2020-12-30, completion 2020-12-30, first posted 2020-06-18, last updated 2022-01-11
Locations	2 sites in United States

-Summary

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

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+Arms and interventions

Votiva device (Device): A retrospective chart review of the medical records

+Outcome measures

Primary outcomes

Participant satisfaction post treatment [4 weeks post treatment]: • Participant satisfaction post treatment. Number of patients who are satisfied with post treatment results \[ Time Frame: Baseline to 4 weeks post-treatment/s\]

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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 Criteria:

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

+Locations (2)

Facility	City	Country	Status
Advanced Women's Care of the Lowcountry	Hilton Head Island, South Carolina	United States
Owen Health Group	Lubbock, Texas	United States

My Notes

Public

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