Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT03123367
Status:
COMPLETED
Last Update Posted:
2018-03-16
First Post:
2017-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Nella Women's Care Line
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2017-03-05', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Feasibility', 'timeFrame': 'Day of Exam or Procedure', 'description': 'Cervical visualization and access'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Day of Exam or Procedure', 'description': 'Number of Adverse Events (AEs)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['GYN Disorders']}, 'descriptionModule': {'briefSummary': "Evaluation of the Nella Women's Care Line", 'detailedDescription': "The Nella Women's Care Line is being studied in women undergoing a gynecological exam and other gynecological procedures that require visibility and access to the cervix."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'General inclusion criteria (applies to all study groups):\n\n* Subject is female\n* Subject is 18 - 65 years of age, inclusive, at the time of consent\n* Subject is undergoing a gynecological examination (as defined above) as part of their regular clinical care\n* Subject has undergone one or more prior gynecological exams\n* Subject is willing and able to provide written informed consent\n* Subject is able and willing to perform the functions required by the study protocol\n\nGeneral exclusion criteria (applies to all study groups):\n\n* Subject has undergone hysterectomy\n* Subject has a known history of allergies to latex or plastics\n* Subject is pregnant\n* Subject is post-partum (≤ 12 weeks)\n* Subject has had an induced or spontaneous abortion in the prior 12 weeks\n* Subject has an active gynecologic complaint that, in the opinion of the clinician, would confound study results\n* Subject has dyspareunia\n* Subject has a known history of vulvodynia such as vulvular vestibular syndrome\n* Subject has a known history of vaginismus\n* Subject has a planned surgical procedure along with the gynecological exam\n* Subject is under incarceration\n* Subject is unable to provide written informed consent\n\nDevice specific inclusion criteria:\n\nIn addition to the general inclusion, the subject must meet all device specific criteria associated with their assignment group. Below are device-specific criteria. There is no device-specific exclusion criterion.\n\nNella VuSleeve (Group 1) inclusion:\n\n• Subject has a BMI ≥ 30 and/or 3 or more vaginal births\n\nNellaSpec (Group 2), Nella NuSpec (Group 3), and Nella Insert (Group 4) inclusion:\n\n• Subject has a BMI \\< 35'}, 'identificationModule': {'nctId': 'NCT03123367', 'briefTitle': "Evaluation of the Nella Women's Care Line", 'organization': {'class': 'INDUSTRY', 'fullName': 'Ceek Enterprises'}, 'officialTitle': "An Evaluation of the Safety and TechnIcal Feasibility Of the NelLa Women's Care Line for Female Gynecological ExaminaTions and Procedures (VIOLET)", 'orgStudyIdInfo': {'id': 'CLP-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1: Nella VuSleeve', 'description': 'Sleeve', 'interventionNames': ['Device: Group 1: Nella VuSleeve']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Nella NuSpec', 'description': 'Speculum', 'interventionNames': ['Device: Group 2: Nella NuSpec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3: NellaSpec', 'description': 'Speculum', 'interventionNames': ['Device: Group 3: NellaSpec']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4: Nella Insert', 'description': 'Sleeve', 'interventionNames': ['Device: Group 4: Nella Insert']}], 'interventions': [{'name': 'Group 1: Nella VuSleeve', 'type': 'DEVICE', 'description': 'Sleeve', 'armGroupLabels': ['Group 1: Nella VuSleeve']}, {'name': 'Group 2: Nella NuSpec', 'type': 'DEVICE', 'description': 'Speculum', 'armGroupLabels': ['Group 2: Nella NuSpec']}, {'name': 'Group 3: NellaSpec', 'type': 'DEVICE', 'description': 'Speculum', 'armGroupLabels': ['Group 3: NellaSpec']}, {'name': 'Group 4: Nella Insert', 'type': 'DEVICE', 'description': 'Sleeve', 'armGroupLabels': ['Group 4: Nella Insert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97209', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Ceek Clinical Research', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ceek Enterprises'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ceek Enterprises', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}