Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:23 AM
Study NCT ID:
NCT07367061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an open, double-arm, prospective, multicenter clinical investigation to evaluate the safety and efficacy of INNEA AQUA in adult women aged 18-75 with Vulvo-vaginal atrophy (VVA). The enrollment period will be 6 months, and the clinical investigation period will be up to 12 weeks per patient.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety: Incidence of AE and SAE', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Efficacy: change in pruritus', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in Pruritus (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120'}, {'measure': 'Efficacy: Change in soreness', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in Soreness (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120'}, {'measure': 'Efficacy: change in dyspareunia', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in Dyspareunia (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120'}, {'measure': 'efficacy: change in irritation', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in Irritation (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120'}, {'measure': 'efficacy: evaluation of pH', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Vaginal Ph Normalization'}, {'measure': 'efficacy: change in vaginal moisture', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in Vaginal moisture - Modified Schirmer test (mm) change on Day 30, Day 51, and Day 120 compared with baseline'}, {'measure': 'efficacy: change in VHX', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in Vaginal Health Index (VHI) score on Day 30, Day 51, and Day 120'}, {'measure': 'efficacy: evaluation of vaginal aging', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in Day-to-Day Impact of Vaginal Aging Questionnaire on Day 30, Day 51, and Day 120'}, {'measure': 'safety (AE/SAE)', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not'}, {'measure': 'efficacy: satisfaction of the patient', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Participant satisfaction in using the Device (PGI-I) Day 120'}, {'measure': 'efficacy: satisfaction of the investigator', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Investigator satisfaction in using the Device (VAS) Day 120'}, {'measure': 'efficacy: evaluation of quality of life', 'timeFrame': 'From enrollment to the end of treatment and second follow up visit at 120 days from the first injection', 'description': 'Change in baseline score in QoL score when compared to Day 30, 51 and 120.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VVA', 'hyaluronic acid', 'vulvo vaginal atrophy', 'vaginal atrophy'], 'conditions': ['Vulvo Vaginal Atrophy']}, 'descriptionModule': {'briefSummary': 'Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).\n\nTo assess the Safety and efficacy of INNEA AQUA', 'detailedDescription': 'Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).\n\nTo assess the Safety and efficacy of INNEA AQUA'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female (18-75 Years old)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women aged 18-75 (both fertile and post-menopausal)\n* Vulvovaginal atrophy diagnostic\n* Signed written informed consent.\n* Vaginal Ph more than 4.5\n* Willing to sign the informed consent form\n* Willing to comply with the clinical investigation visits.\n\nExclusion Criteria:\n\n* patients who tend to develop hypertrophic scarring,\n* patients with a history of autoimmune disease or who are receiving immune therapy,\n* patients who are known to be hypersensitive or allergic to hyaluronic acid and other INNEA AQUA components,\n* pregnant or breastfeeding women,\n* patients under 18 years of age,\n* vagina with hypertrophic scars from different etiology,\n* patients with presence of ≥ stage 2 apical pelvic organ prolapse,\n* patients with stress urinary incontinence,\n* patients with vaginismus, vulvovaginal or urinary tract infection,\n* patients with Hemorrhagic or neoplastic genital pathologies or hormone-dependent tumor\n* 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,\n* Anticoagulated patients or patients receiving platelet aggregation inhibitors should not be treated with INNEA AQUA,\n* 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,\n* Avoid using in combination with any other concomitant therapies for same indication;\n* 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.'}, 'identificationModule': {'nctId': 'NCT07367061', 'briefTitle': 'Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innate srl'}, 'officialTitle': 'Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)', 'orgStudyIdInfo': {'id': 'INN-AQA-10/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: randomized to the treatment Innea Aqua', 'description': '31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection', 'interventionNames': ['Device: product: Innea Aqua vaginal use']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: randomized to the treatment to the standard of care', 'description': 'standard of care tratment', 'interventionNames': ['Device: arm 2: standard of care']}], 'interventions': [{'name': 'product: Innea Aqua vaginal use', 'type': 'DEVICE', 'description': 'product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.', 'armGroupLabels': ['Arm 1: randomized to the treatment Innea Aqua']}, {'name': 'arm 2: standard of care', 'type': 'DEVICE', 'description': 'the comparator is the standard of care selected by the centre', 'armGroupLabels': ['Arm 2: randomized to the treatment to the standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '011132', 'city': 'Bucharest', 'state': 'Romania', 'country': 'Romania', 'facility': 'Obstretics and Gynaecology Filantropia Clinical Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '022441', 'city': 'Bucharest', 'state': 'Romania', 'country': 'Romania', 'facility': 'Nicolae Malaxa Clinical Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '030863', 'city': 'Bucharest', 'state': 'Romania', 'country': 'Romania', 'facility': 'AMCA Medical Clinic', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innate srl', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CEBIS International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}