Vaginal AtrophyNCT05398172
Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
A study testing MorpheusV Applicator in people with Vaginal Atrophy, run by InMode MD Ltd. at 2 sites in United States.
Trial summary
Prospective, one arm, baseline-controlled At least 30 healthy adult female volunteers, from 2 investigational sites seeking treatment for Symptoms of Vulvovaginal Atrophy Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol The subject will return for… Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- MorpheusV Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2021to 18 Jun 2024
- Phase
- Interventional
- 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 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent to participate in the study.
- BMI < 36
- VHIS<15
- Healthy non-smoking female subjects, > 35 and < 75 years of age at the time of enrolment post menopausal with absence of menstruation of at least 12 months
- General good health confirmed by medical history and examination of the treated area.
- The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other treatment methods in the treated area for the last 6 months and during the entire study period.
Who cannot join
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
- Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Pregnancy and nursing.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
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- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
- Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
- Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
- Any surgery in treated area within 3 months prior to treatment.
- Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
- Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
- Acute urinary tract infection (UTI), or genital infection (e.g. IVU, herpes genitalis, candida).
- Treatment with any Vaginal Estrogen medication within 30 days
- Prolapse beyond hymen
- Any chronic condition that could interfere with study compliance
- Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
- As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute for Female Pelvic Medicine
Knoxville, Tennessee, 37932
Beyond Regenerative Medicine and Aesthetics
Newport Beach, California, 92660
About this study
Prospective, one arm, baseline-controlled At least 30 healthy adult female volunteers, from 2 investigational sites seeking treatment for Symptoms of Vulvovaginal Atrophy Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol The subject will return for 3 follow up visits: 3 months follow up (3M FU), 6 months follow up (6M FU), 12months follow up (12M FU) after the treatment.
Total expected study duration is approximately 12 months.
- Conditions
- Vaginal Atrophy
- Being tested
- MorpheusV Applicator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorpheusV ApplicatorDevice
Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | 3 treatments once a month Receives: Device: MorpheusV Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of treatment on VVA symptoms,
effect of treatment on VVA symptoms, such as pain, vaginal burning, vaginal itching, dyspareunia and dysuria, using the Visual Analog Scale (VAS). scored from 1 to 10, the lower the score the better the outcome
Measured: baseline through 12 months
objective evaluation of vaginal atrophy/estrogenization
measured by the globally validated "Vaginal Health Index" (VHI) score at follow up visits 3M, 6M FU and 12M FU) compared to Baseline. Scored from 5 to 25, the higher the score the better the outcome
Measured: baseline through 12 months
Assess the effect of treatment on the general quality of life,
by mean of the "Short Form 12" (SF-12) specific questionnaire. Administered at baseline and at follow up visits 3M, 6M and 12M FU).
Measured: baseline through 12 months
The effect of the treatment on Sexual Function
measured by Female Sexual Function Index (FSFI) at follow up visits (3M FU,6M FU and 12M FU) compared to baseline. the higher the score the better the outcome
Measured: baseline through 12 months
Assess the degree of difficulty encountered by the physician in performing the treatment,
by mean of a 5-point Likert scale. the higher the score the better the outcome
Measured: baseline through 12 months
The rate of satisfaction of patients with treatment
assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale. The subjects will answer this questionnaire at follow up visits 3M FU, 6M and 12M FU). the higher the score the better the outcome
Measured: baseline through 12 months
The effect of the treatment on urinary symptoms
by means of Urogenital Distress Inventory 6 Questionnaire. Administered at baseline and at each follow up visit (3M FU, 6M FU, 12M FU). the lower the score the better the outcome
Measured: baseline through 12 months
Secondary outcomes (3)
Occurrence of expected post-treatment adverse events
Occurrence of expected post treatment immediate response including erythema and edema and during all study period based on predefined scale
Measured: up to 12 months
Discomfort scale
A 10cm visual analog scale from 0 (no discomfort) to 10 (worst possible discomfort) to measure discomfort associated with probe insertion, and RF energy application at the treatment visit
Measured: up to 3 months
Adverse events
Number, severity and type of any adverse event recorded throughout the course of the study.
Measured: baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start10 Aug 2021
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT05398172
- Sponsor's protocol ID
- DO610363A
- Status last verified
- Sep 2024
- First submitted
- 17 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
- ClinicalTrials.gov ID
- NCT05398172
- Acronym / sponsor ID
- DO610363A
- Conditions
- Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 31 May 2022 (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.
Prospective, one arm, baseline-controlled At least 30 healthy adult female volunteers, from 2 investigational sites seeking treatment for Symptoms of Vulvovaginal Atrophy Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol The subject will return for 3 follow up visits: 3 months follow up (3M FU), 6 months follow up (6M FU), 12months follow up (12M FU) after the treatment.
Total expected study duration is approximately 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: MorpheusV Applicator3 treatments once a month |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent to participate in the study.
- BMI < 36
- VHIS<15
- Healthy non-smoking female subjects, > 35 and < 75 years of age at the time of enrolment post menopausal with absence of menstruation of at least 12 months
- General good health confirmed by medical history and examination of the treated area.
Key exclusion criteria (20 listed)
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
- Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles.
- Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
- Pregnancy and nursing.
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 |
|---|---|---|
| MorpheusV ApplicatorEligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol | Device | treatment |
Primary outcome
effect of treatment on VVA symptoms,
Time frame: baseline through 12 months
effect of treatment on VVA symptoms, such as pain, vaginal burning, vaginal itching, dyspareunia and dysuria, using the Visual Analog Scale (VAS). scored from 1 to 10, the lower the score the better the outcome
objective evaluation of vaginal atrophy/estrogenization
Time frame: baseline through 12 months
measured by the globally validated "Vaginal Health Index" (VHI) score at follow up visits 3M, 6M FU and 12M FU) compared to Baseline. Scored from 5 to 25, the higher the score the better the outcome
Assess the effect of treatment on the general quality of life,
Time frame: baseline through 12 months
by mean of the "Short Form 12" (SF-12) specific questionnaire. Administered at baseline and at follow up visits 3M, 6M and 12M FU).
The effect of the treatment on Sexual Function
Time frame: baseline through 12 months
measured by Female Sexual Function Index (FSFI) at follow up visits (3M FU,6M FU and 12M FU) compared to baseline. the higher the score the better the outcome
Assess the degree of difficulty encountered by the physician in performing the treatment,
Time frame: baseline through 12 months
by mean of a 5-point Likert scale. the higher the score the better the outcome
The rate of satisfaction of patients with treatment
Time frame: baseline through 12 months
assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale. The subjects will answer this questionnaire at follow up visits 3M FU, 6M and 12M FU). the higher the score the better the outcome
The effect of the treatment on urinary symptoms
Time frame: baseline through 12 months
by means of Urogenital Distress Inventory 6 Questionnaire. Administered at baseline and at each follow up visit (3M FU, 6M FU, 12M FU). the lower the score the better the outcome
3 secondary outcomes
Occurrence of expected post-treatment adverse events
Time frame: up to 12 months
Discomfort scale
Time frame: up to 3 months
Adverse events
Time frame: baseline through 12 months
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing MorpheusV Applicator in people with Vaginal Atrophy, 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 6 inclusion and 20 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 19 Sep 2024. 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?
effect of treatment on VVA symptoms, (time frame: baseline through 12 months). The study lists 7 primary outcomes in all. 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 19 Sep 2024.