Back to resultsClinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
Primary Purpose
Vaginal Atrophy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MorpheusV Applicator
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Atrophy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Beyond Regenerative Medicine and AestheticsRecruiting
- Institute for Female Pelvic MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment
Arm Description
3 treatments once a month
Outcomes
Primary Outcome Measures
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
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
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).
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
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
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
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
Secondary Outcome Measures
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
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
Adverse events
Number, severity and type of any adverse event recorded throughout the course of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05398172
Brief Title
Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
Official Title
Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InMode MD Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
3 treatments once a month
Intervention Type
Device
Intervention Name(s)
MorpheusV Applicator
Intervention Description
Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol
Primary Outcome Measure Information:
Title
effect of treatment on VVA symptoms,
Description
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
Time Frame
baseline through 12 months
Title
objective evaluation of vaginal atrophy/estrogenization
Description
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
Time Frame
baseline through 12 months
Title
Assess the effect of treatment on the general quality of life,
Description
by mean of the "Short Form 12" (SF-12) specific questionnaire. Administered at baseline and at follow up visits 3M, 6M and 12M FU).
Time Frame
baseline through 12 months
Title
The effect of the treatment on Sexual Function
Description
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
Time Frame
baseline through 12 months
Title
Assess the degree of difficulty encountered by the physician in performing the treatment,
Description
by mean of a 5-point Likert scale. the higher the score the better the outcome
Time Frame
baseline through 12 months
Title
The rate of satisfaction of patients with treatment
Description
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
Time Frame
baseline through 12 months
Title
The effect of the treatment on urinary symptoms
Description
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
Time Frame
baseline through 12 months
Secondary Outcome Measure Information:
Title
Occurrence of expected post-treatment adverse events
Description
Occurrence of expected post treatment immediate response including erythema and edema and during all study period based on predefined scale
Time Frame
up to 12 months
Title
Discomfort scale
Description
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
Time Frame
up to 3 months
Title
Adverse events
Description
Number, severity and type of any adverse event recorded throughout the course of the study.
Time Frame
baseline through 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Shusterman
Phone
9057076787
Email
Maria.Shusterman@inmodemd.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leon Grach
Phone
9057076787
Email
Leon.Grach@inmodemd.com
Facility Information:
Facility Name
Beyond Regenerative Medicine and Aesthetics
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Kopinga
Email
eanobil@gmail.com
First Name & Middle Initial & Last Name & Degree
Mickey Karram, MD
Facility Name
Institute for Female Pelvic Medicine
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37932
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Yeomans
Email
nyeomans@IFPM.net
First Name & Middle Initial & Last Name & Degree
Jeffrey R Dell, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
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