Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)

Innate srl

Status: Active, not recruiting

Conditions: Vulvo Vaginal Atrophy

Treatments: Device: arm 2: standard of care; Device: product: Innea Aqua vaginal use

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07367061

INN-AQA-10/24

Details and patient eligibility

About

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

Full description

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

Enrollment: 62 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Arm 1: randomized to the treatment Innea Aqua

Experimental group

Description:

31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection

Treatment:

Device: product: Innea Aqua vaginal use

Arm 2: randomized to the treatment to the standard of care

Active Comparator group

Description:

standard of care tratment

Treatment:

Device: arm 2: standard of care