Retrospective Chart Review Study of Patients Treated With Votiva Device

Vulvovaginal Signs and Symptoms Clinical Trial

Official title:

Retrospective Chart Review Study of Patients Treated With Votiva Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437680
• Other study ID #: DO609635A
• Status: Completed
• Start date: June 5, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2022
• Source: InMode MD Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vulvovaginal Signs and Symptoms

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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