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Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuEra Tight VRF Handpiece | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| To evaluate the treatment effect on sexual function and overall satisfaction with sexual life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gally Glass, M.Sc. | Contact | +972.4.9099.455 | gally.glass@lumenis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYDerm | Recruiting | New York | New York | 10028 | United States |
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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.
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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. |
| 12 months |
| Secondary Objective - 3 | To evaluate improvement in the appearance of the vulva and vaginal lips /genitals (optional) | 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 | 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. | 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. | 12 months |