Retrospective Chart Review Study of Patients Treated With Votiva Device

NCT04437680 | Completed FDA Device

• 1 other identifier: DO609635A
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Vulvovaginal Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• Participant satisfaction post treatment

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

  4 weeks post treatment

Interventions

Votiva device DEVICE

A retrospective chart review of the medical records

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A retrospective chart review of the medical records of 2 practices will be performed by investigators listed in the approved IRB protocol. Patients are seen at 1 site from August 2018 - May 2020, at 2nd site from September 2018 - February 2020 will be included. Patents who have received RF treatment with Votiva will be identified and selected.

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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (2)

Advanced Women's Care of the Lowcountry

Hilton Head Island, South Carolina, 29926, United States

Location

Owen Health Group

Lubbock, Texas, 79424, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: June 5, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)