Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:31 AM
Study NCT ID:
NCT07445958
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019522', 'term': 'Vaginal Discharge'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Grade ≥2 vaginal mucosal trauma', 'timeFrame': 'Immediate post-use (within 5 minutes of device removal)', 'description': 'Incidence of Grade ≥2 vaginal mucosal trauma assessed immediately after device removal via digital colposcopic examination. Mucosal trauma defined as: Grade 2 (Moderate): Abrasion \\>5 mm or multiple foci totaling \\>10 mm; pinpoint bleeding stopping spontaneously. Grade 3 (Severe): Laceration or bleeding requiring medical intervention.'}], 'secondaryOutcomes': [{'measure': 'Pain/discomfort during insertion/removal', 'timeFrame': 'During Visit 1, immediately after device insertion/removal, and at 24-hours (+/- 6 hr)', 'description': 'Immediately after device insertion and removal, Numeric Rating Scale (0- no pain to 10- maximum pain) will be self-reported by patient.'}, {'measure': 'Ease of use', 'timeFrame': 'During Visit 1 immediately following third device insertion', 'description': 'Likert scale on ease of overall device use - Very Easy, Easy, Neither Easy Nor Difficult, Difficult, Very Difficult'}, {'measure': 'Spotting or pain within 24 hours post-use', 'timeFrame': '24-hour (+/- 6hr) follow-up', 'description': 'self-reported by subject on e-diary or telephone survey'}, {'measure': 'Allergy and Hypersensitivity Responses', 'timeFrame': 'after each study device removal, and up to 7 days following visit 1', 'description': 'Mucosal changes consistent with allergy or hypersensitivity (eg edema, urticaria, swelling, itching) will be documented - this will be both reported subjectively by the patient, and objectively reported by the clinician using digital colposcopy examinations.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['tampon device', 'postcoital', 'vaginal mucosa', 'device safety', 'sexual intercourse', 'pelvic exam'], 'conditions': ['Vaginal Discharge', 'Postcoital Vaginal Changes']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the Livi postcoital tampon device is safe for repetitive use in sexually active women aged 18 years and older. The main question it aims to answer is:\n\nDoes using the Livi device three times in a row cause any visible vaginal mucosal trauma? How much pain or discomfort do participants experience during insertion and removal?\n\nResearchers will not compare the Livi device to another product because this is a single-arm safety study.\n\nParticipants will:\n\n* Insert and remove the Livi device three times consecutively during one clinic visit\n* Undergo a baseline speculum exam and digital colposcopy exams after each device removal to check vaginal tissue\n* Complete a 24-hour follow-up via e-diary or phone call to report pain, spotting, or other symptoms\n* Report any unsolicited symptoms for 7 days after use'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sexually active women aged ≥18 years\n* Able and willing to comply with all study procedures\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Current pregnancy or within 6 weeks postpartum\n* Symptomatic vaginal infection, lesion, or vulvovaginal discomfort at baseline\n* Known allergy to any component of the study device\n* Pelvic or vaginal surgery within the past 6 weeks\n* Any medical or psychological condition that, in the investigator's opinion, may interfere with participation or safety"}, 'identificationModule': {'nctId': 'NCT07445958', 'briefTitle': 'In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device', 'orgStudyIdInfo': {'id': 'LIV-SAF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Livi Device Safety Evaluation', 'description': 'Participants will insert and remove the Livi device three times consecutively during a single clinic visit.', 'interventionNames': ['Device: Livi Postcoital Tampon Device']}], 'interventions': [{'name': 'Livi Postcoital Tampon Device', 'type': 'DEVICE', 'description': 'Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse.', 'armGroupLabels': ['Livi Device Safety Evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07046', 'city': 'Mountain Lakes', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Garden State Urology', 'geoPoint': {'lat': 40.89482, 'lon': -74.43293}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Michael Ingber', 'investigatorAffiliation': 'Atlantic Health System'}}}}