NCT07367061进行中（未招募）不适用
Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)
Innate srl3 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年9月25日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- safety: Incidence of AE and SAE
研究概览
简要总结
Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).
To assess the Safety and efficacy of INNEA AQUA
详细描述
Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).
To assess the Safety and efficacy of INNEA AQUA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women aged 18-75 (both fertile and post-menopausal)
- •Vulvovaginal atrophy diagnostic
- •Signed written informed consent.
- •Vaginal Ph more than 4.5
- •Willing to sign the informed consent form
- •Willing to comply with the clinical investigation visits.
排除标准
- •patients who tend to develop hypertrophic scarring,
- •patients with a history of autoimmune disease or who are receiving immune therapy,
- •patients who are known to be hypersensitive or allergic to hyaluronic acid and other INNEA AQUA components,
- •pregnant or breastfeeding women,
- •patients under 18 years of age,
- •vagina with hypertrophic scars from different etiology,
- •patients with presence of ≥ stage 2 apical pelvic organ prolapse,
- •patients with stress urinary incontinence,
- •patients with vaginismus, vulvovaginal or urinary tract infection,
- •patients with Hemorrhagic or neoplastic genital pathologies or hormone-dependent tumor
- •patients with genital bleeding of unknown etiology, recurrent porphyria, uncontrolled epilepsy, heart conduction disorders, recurrent angina, rheumatic fever, previous vulvovaginal or uro-gynecological surgery, and hemostatic disorders,
- •Anticoagulated patients or patients receiving platelet aggregation inhibitors should not be treated with INNEA AQUA,
- •INNEA AQUA must not be used in areas presenting inflammatory and/or infectious processes (e.g., papilloma, herpes). INNEA AQUA must not be used in association with other invasive treatments,
- •Avoid using in combination with any other concomitant therapies for same indication;
- •Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites.
研究组 & 干预措施
Arm 1: randomized to the treatment Innea Aqua
Experimental
31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection
干预措施: product: Innea Aqua vaginal use (Device)
Arm 2: randomized to the treatment to the standard of care
Active Comparator
standard of care tratment
干预措施: arm 2: standard of care (Device)
结局指标
主要结局
safety: Incidence of AE and SAE
时间窗: From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
To evaluate the safety of INNEA AQUA in adult participants. Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not
次要结局
- Efficacy: change in pruritus(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- Efficacy: Change in soreness(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- Efficacy: change in dyspareunia(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: change in irritation(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: evaluation of pH(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: change in vaginal moisture(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: change in VHX(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: evaluation of vaginal aging(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- safety (AE/SAE)(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: satisfaction of the patient(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: satisfaction of the investigator(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
- efficacy: evaluation of quality of life(From enrollment to the end of treatment and second follow up visit at 120 days from the first injection)
研究者
研究点 (3)
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