Vulvovaginal Signs and SymptomsNCT04437680
Retrospective Chart Review Study of Patients Treated With Votiva Device
An observational study of Vulvovaginal Signs and Symptoms, run by InMode MD Ltd. at 2 sites in United States.
Trial summary
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Signs and Symptoms
- What is being tested?
- Votiva device
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Women's Care of the Lowcountry
Hilton Head Island, South Carolina, 29926
Owen Health Group
Lubbock, Texas, 79424
About this study
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.
- Conditions
- Vulvovaginal Signs and Symptoms
- Being tested
- Votiva device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Votiva deviceDevice
A retrospective chart review of the medical records
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 4 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start5 Jun 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal Signs and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437680
- Sponsor's protocol ID
- DO609635A
- Status last verified
- Jan 2022
- First submitted
- 16 Jun 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review Study of Patients Treated With Votiva Device
- ClinicalTrials.gov ID
- NCT04437680
- Acronym / sponsor ID
- DO609635A
- Conditions
- Vulvovaginal Signs and Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Votiva deviceA retrospective chart review of the medical records | Device | – |
Primary outcome
Participant satisfaction post treatment
Time frame: 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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginal Signs and Symptoms, run by InMode MD Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction post treatment (time frame: 4 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.