Evaluation of the Safety and Efficacy of the NuEra Tight VRF for the Treatment of Vaginal and Vulvar Tissue Laxity
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and Efficacy of the NuEra small area handpiece
研究概览
简要总结
Up to twenty (20) healthy pre- and post-menopausal women with self-reported vaginal laxity will be enrolled in the study.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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
- •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
结局指标
主要结局
Safety and Efficacy of the NuEra small area handpiece
时间窗: 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.
次要结局
- To evaluate the long-term effect on vaginal tissue laxity in pre- and post-menopausal women.(12 months)
- To evaluate overall improvement following the treatment.(12 months)
- To evaluate the treatment effect on the general vaginal health.(12 months)
- To evaluate the treatment effect on sexual function and overall satisfaction with sexual life(12 months)
- To evaluate procedure-related subject treatment pain and discomfort(12 months)
- Secondary Objective - 3(12 months)