Vagina AtrophyNCT04511260
Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
A study testing NuEra Tight VRF Handpiece in people with Vagina Atrophy, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vagina Atrophy
- What is being tested?
- NuEra Tight VRF Handpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 20 Jun 2021
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age between 35 to 60
- Last vaginal delivery is at least 12 months prior to enrollment
- Self-reported vaginal laxity defined as "very loose," "moderately loose," or "slightly loose" on the Vaginal Laxity Questionnaire (VLQ)
- Sexual activity≥ once per month, with a same partner
- Willing to use contraception for the duration of the study
- Negative urine analysis
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- Negative pregnancy test
- Patient is not pregnant nor planning to become pregnant throughout the duration of the study
- Willing to improve vaginal lips / genitals appearance (optional)
- Normal gynecological exam from the recent year
- If taking probiotics and/or any other supplement or suppository as part of daily regimen, willing to maintain same regimen throughout the entire duration of the study
- Able and willing to comply with the treatment/follow-up schedule and requirements ·
- Willing to sign an informed consent
Who cannot join
- Previous pelvic floor reconstructive surgery with mesh.
- Pelvic organ prolapse (POP) >II according to the pelvic organ prolapse quantification system
- Pregnant or lactating
- Women in post-menopausal stage for more than five years.
- Active genital infection or sexually transmitted diseases
- Subject presenting abnormal Pap smear result from the last five years with any of the following findings according to the Bethesda System (2001) classification: A.. Atypical Squamous Cells-cannot exclude high grade squamous intraepithelial lesion B. Atypical Glandular Cells (Endocervical, Endometrial not otherwise specified) C. High Grade squamous intraepithelial lesion (HSIL)D. Carcinoma
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- Patients with implantable devices, such as but not limited to pacemakers, implanted defibrillators, and Cochlear ear implant
- Serious systemic disease or any chronic condition that could interfere with study compliance
- Has metal implant(s) within the treated area, such as surgical clips, plates and screws, intrauterine device (IUD) or artificial joints
- History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
- History of vaginal tissue disease in the treatment area
- Taken part in a clinical trial involving an investigational drug or device within 30 days prior to screening and through the study duration
- Presence of Vulvar lesions or any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
- Nerve insensitivity to heat anywhere in the treatment area, since ongoing feedback by a patient during a procedure is required
- Previous treatment with a vaginal energy based device, including laser treatment.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NYDerm
New York, New York, 10028
NYDerm, 212-570-2067, email@nyderm.org
Macrene Alexiades, MD
About this study
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
Read the detailed description
The treatment will include: A treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece (optional).
This is a single center, prospective, open label, single arm study. Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment.
- Conditions
- Vagina Atrophy
- Being tested
- NuEra Tight VRF Handpiece
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuEra Tight VRF HandpieceDevice
The VRF is a Model that belongs to the NuEra Tight RF Family, specific for the treatment of small areas.
The NuEra is FDA cleared (K151296) for a wide range of indications including but not limited to, selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The NuEra Tight VRF with the small area handpiece is CE marked in Europe and currently under review by the FDA. The system and its accessories, are intended to be use for a wide range of indications including, but not limited to:
- Provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation of soft tissue.
| Study group | Role | What they receive |
|---|---|---|
| VRF Treatment | Experimental | A treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece (optional).
Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment. Receives: Device: NuEra Tight VRF Handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of the NuEra small area handpiece
Evaluation of safety and short-term performance of the NuEra small area handpiece treatment on vaginal tissue laxity in pre- and post-menopausal women.
Change in vaginal laxity as measured by the subject reported laxity rating on a Vaginal Laxity Questionnaire (VLQ) 7-point scale at 1-month follow-up visit compared to baseline. Safety endpoints will include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial or follow-up.
Measured: 12 months
Secondary outcomes (6)
To evaluate the long-term effect on vaginal tissue laxity in pre- and post-menopausal women.
Change in vaginal laxity as measured by the subject reported laxity rating on a Vaginal Laxity Questionnaire (VLQ) 7-point scale at 3-months follow-up visit compared to baseline.
Measured: 12 months
To evaluate the treatment effect on sexual function and overall satisfaction with sexual life
Change in sexual function as evaluated by the subject Female Sexual Function Index (FSFI) at 1, and 3 months follow up visits compared to baseline.
Measured: 12 months
Secondary Objective - 3
To evaluate improvement in the appearance of the vulva and vaginal lips /genitals (optional)
Measured: 12 months
To evaluate overall improvement following the treatment.
(Optional) Improvement in visual appearance of the vaginal lips /genitals, self-assessed by women at 3 months follow up visit compared to baseline (optional- will be assessed in women receiving treatment for this purpose) - by B\&A photos
Measured: 12 months
To evaluate the treatment effect on the general vaginal health.
Subject satisfaction with the treatment using a 5-point Likert scale from post first treatment and after the three months follow up visits by SSQ and Patient Global Impression of Improvement (PGI-I) determined as score of 1-3 (very much better-a little better).
Change in a physician-reported general vaginal health rating on a VHIS at 1 and 3 months follow up visits compared to baseline.
Measured: 12 months
To evaluate procedure-related subject treatment pain and discomfort
Subject assessment of pain and discomfort that is procedure related using a visual a Pain Visual Analogue Scale (PVAS), evaluated at each treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start16 Oct 2020
- Primary completion20 Jun 2021 (estimated)
- Study completion20 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vagina 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
- Model description
- The NuEra device family is FDA cleared (K151296) for a wide range of indications including, but not limited to, selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The NuEra Tight - model VRF with the small area handpiece is CE marked in Europe and currently under review by the FDA. In this study, the Radio Frequency treatment will be administered in a continuous motion to the vaginal mucosa and the introitus using the small area handpiece.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511260
- Sponsor's protocol ID
- LUM-ABU- NuEra VRF 20-01
- Status last verified
- Dec 2020
- First submitted
- 5 Aug 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
- ClinicalTrials.gov ID
- NCT04511260
- Acronym / sponsor ID
- LUM-ABU- NuEra VRF 20-01
- Conditions
- Vagina Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- 20 Jun 2021 (estimated)
- First posted
- 13 Aug 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.
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
Detailed description
The treatment will include: A treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece (optional).
This is a single center, prospective, open label, single arm study. Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The NuEra device family is FDA cleared (K151296) for a wide range of indications including, but not limited to, selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The NuEra Tight - model VRF with the small area handpiece is CE marked in Europe and currently under review by the FDA. In this study, the Radio Frequency treatment will be administered in a continuous motion to the vaginal mucosa and the introitus using the small area handpiece.
| Arm | Type | Receives |
|---|---|---|
| VRF Treatment | Experimental | Device: NuEra Tight VRF HandpieceA treatment of the vaginal canal using the NuEra Tight VRF small area handpiece. A treatment of the introitus and vestibule using the NuEra Tight VRF small area hand piece (optional). Following screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments, 4 weeks apart and 2 Follow Up (FU) visits, at 1, and 3 months following the last treatment. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Women age between 35 to 60
- Last vaginal delivery is at least 12 months prior to enrollment
- Self-reported vaginal laxity defined as "very loose," "moderately loose," or "slightly loose" on the Vaginal Laxity Questionnaire (VLQ)
- Sexual activity≥ once per month, with a same partner
- Willing to use contraception for the duration of the study
Key exclusion criteria (16 listed)
- Previous pelvic floor reconstructive surgery with mesh.
- Pelvic organ prolapse (POP) >II according to the pelvic organ prolapse quantification system
- Pregnant or lactating
- Women in post-menopausal stage for more than five years.
- Active genital infection or sexually transmitted diseases
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 |
|---|---|---|
| NuEra Tight VRF HandpieceThe VRF is a Model that belongs to the NuEra Tight RF Family, specific for the treatment of small areas. The NuEra is FDA cleared (K151296) for a wide range of indications including but not limited to, selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The NuEra Tight VRF with the small area handpiece is CE marked in Europe and currently under review by the FDA. The system and its accessories, are intended to be use for a wide range of indications including, but not limited to: · Provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation of soft tissue. | Device | VRF Treatment |
Primary outcome
Safety and Efficacy of the NuEra small area handpiece
Time frame: 12 months
Evaluation of safety and short-term performance of the NuEra small area handpiece treatment on vaginal tissue laxity in pre- and post-menopausal women. Change in vaginal laxity as measured by the subject reported laxity rating on a Vaginal Laxity Questionnaire (VLQ) 7-point scale at 1-month follow-up visit compared to baseline. Safety endpoints will include adverse events (AEs) and serious adverse events (SAEs) occurring at any time during the trial or follow-up.
6 secondary outcomes
To evaluate the long-term effect on vaginal tissue laxity in pre- and post-menopausal women.
Time frame: 12 months
To evaluate the treatment effect on sexual function and overall satisfaction with sexual life
Time frame: 12 months
Secondary Objective - 3
Time frame: 12 months
To evaluate overall improvement following the treatment.
Time frame: 12 months
To evaluate the treatment effect on the general vaginal health.
Time frame: 12 months
To evaluate procedure-related subject treatment pain and discomfort
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuEra Tight VRF Handpiece in people with Vagina Atrophy, run by Lumenis Be Ltd. at 1 site 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 13 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gally Glass, M.Sc. (+972.4.9099.455, gally.glass@lumenis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of the NuEra small area handpiece (time frame: 12 months). 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 8 Dec 2020.