Retrospective Chart Review Study of Patients Treated With Votiva Device

NCT ID: NCT04437680

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-05

Study Completion Date

2020-12-30

Brief Summary

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

Detailed Description

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Conditions

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Vulvovaginal Signs and Symptoms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Votiva device

A retrospective chart review of the medical records

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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InMode MD Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Advanced Women's Care of the Lowcountry

Hilton Head Island, South Carolina, United States

Site Status

Owen Health Group

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DO609635A

Identifier Type: -

Identifier Source: org_study_id

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