Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT05309694
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2022-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm and open-label design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Insertions', 'timeFrame': 'From enrollment to end of treatment at 3 months', 'description': 'The percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt.'}], 'secondaryOutcomes': [{'measure': 'Uterine Perforation and IUD Embedment', 'timeFrame': 'From enrollment to end of treatment at 3 months', 'description': 'Frequency of uterine perforation and IUD embedment'}, {'measure': 'IUS Expulsions and Dislocations', 'timeFrame': 'From enrollment to end of treatment at 3 months', 'description': 'Frequency of IUS expulsions (partial or total) and dislocations'}, {'measure': 'Adverse Events', 'timeFrame': 'From enrollment to end of treatment at 3 months', 'description': 'Frequency of Serious Adverse Events (SAE) and Adverse Events (AE)'}, {'measure': 'Adverse Events related to Procedure', 'timeFrame': 'From enrollment to end of treatment at 3 months', 'description': 'Frequency of AEs related to procedure'}, {'measure': 'Vasovagal Events', 'timeFrame': 'From enrollment to end of treatment at 3 months', 'description': 'Frequency of vasovagal events at the time of insertion'}, {'measure': 'Pelvic Infections', 'timeFrame': 'From enrollment to end of treatment at 3 months', 'description': 'Frequency of pelvic infections related to IUS insertion and use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Contraception', 'Copper Intrauterine Device', 'Intrauterine Device', 'Contraceptive', 'Birth Control', 'IUD', 'IUS', 'Intrauterine System'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '41000288', 'type': 'DERIVED', 'citation': 'Dunsmoor-Su RF, Desai VB, Pandolfi EC, Audette CR, Miller JR, Fuller AE, Brown EL, Hirth RD, Seetal-Kihei KV, McKain LF. Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter. O G Open. 2025 Mar 6;2(2):e068. doi: 10.1097/og9.0000000000000068. eCollection 2025 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.', 'detailedDescription': 'This is a post-market prospective clinical study to be conducted at multiple centers in a single arm and open-label design to evaluate the safety of a new inserter design for Paragard® (intrauterine copper contraceptive). The study will be conducted in female subjects of child bearing potential.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is a postmenarcheal and premenopausal woman of child bearing potential.\n* Subjects are at least 18 years of age, at the time of signing the informed consent.\n* Subject is overtly healthy as determined by medical evaluation.\n\nExclusion Criteria:\n\n* Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy\n* History of previous IUD complications\n* Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion\n* Known anatomical abnormalities of the cervix\n* Presence of acute pelvic inflammatory disease at the time of screening.\n* Postpartum endometritis.\n* Known or suspected uterine or cervical malignancy.\n* Uterine bleeding of unknown etiology.\n* Untreated acute cervicitis or vaginitis or other lower genital tract infection.\n* Conditions associated with increased susceptibility to pelvic infections.\n* Subjects with Wilson's disease."}, 'identificationModule': {'nctId': 'NCT05309694', 'briefTitle': 'A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperSurgical Inc.'}, 'officialTitle': 'A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive', 'orgStudyIdInfo': {'id': 'CSIPD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential', 'interventionNames': ['Combination Product: Paragard® T380A Intrauterine Copper Contraceptive with New Inserter']}], 'interventions': [{'name': 'Paragard® T380A Intrauterine Copper Contraceptive with New Inserter', 'type': 'COMBINATION_PRODUCT', 'description': 'Paragard® IUS with Investigational Inserter combines the current insertion tube and white rod to form a new pre-assembled inserter device that supports a single hand operation.\n\nThe device is used to pass the IUS through the cervical canal and into the uterine cavity and facilitates insertion of the T shaped Paragard® IUS implant into the uterus.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Downtown Women's Healthcare", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': "South Miami Women's Health", 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '30363', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "GYN-CARE Women's Healthcare", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48602', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Valley Ob-Gyn Clinic, PC', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '45005', 'city': 'Franklin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hilltop Obstetrics & Gynecology', 'geoPoint': {'lat': 39.55895, 'lon': -84.30411}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Austin - Women Partners in Health', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Area Ob-Gyn & Fertility', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Clinical Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Robin Kroll, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seattle Clinical Research Center'}, {'name': 'Carol Stamm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Downtown Women's Healthcare"}, {'name': 'Joyce Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "South Miami Women's Health"}, {'name': 'Jacquelyn Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Valley Ob-Gyn Clinic, PC'}, {'name': 'Ronald Hirth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hilltop Obstetrics & Gynecology'}, {'name': 'Mark Akin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Austin Area Ob-Gyn & Fertility'}, {'name': 'Stephanie Reich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Austin - Women Partners in Health'}, {'name': 'Eric L Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "GYN-CARE Women's Healthcare"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperSurgical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}