Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT04919395
Status:
TERMINATED
Last Update Posted:
2024-01-22
First Post:
2021-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Evaluation of a "Clip" Device for Contraceptive Implant Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013525', 'term': 'Surgical Instruments'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Information regarding the planned intervention study model was removed, as the trial did not meet its recruitment goals.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'On the single day that the study was open, it became clear that modifications to the clip would be required. Only late in 2023 did it become clear that any continuation of the project would require a new trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to remove the contraceptive implant device', 'timeFrame': 'During the intervention/procedure/surgery', 'description': 'The amount of time that it takes to remove the contraceptive implant will be noted for both groups.'}, {'measure': 'Length of incision used for the removal of the single rod contraceptive implant device', 'timeFrame': 'During the intervention/procedure/surgery', 'description': 'This will be recorded for both groups.'}], 'secondaryOutcomes': [{'measure': 'Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive', 'timeFrame': 'During the intervention/procedure/surgery', 'description': 'Participants will be asked to rate the pain they experienced during the procedure.\n\nSubjects will choose the face that best illustrates the pain they experienced during the procedure. Each face corresponds to a value on a 0-10 scale, with a higher score corresponding to more pain.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nexplanon removal', 'Medical device'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. The study device may improve the process for removing under arm implants by decreasing procedure time and improving the ease and safety of the procedure.\n\nThe results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This is a study for participants using birth control.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently using Nexplanon and requesting removal\n* Qualifies for outpatient removal\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Any rashes or skin conditions around the insertion site\n* Known allergy to lidocaine\n* Known allergy to biocompatible plastics or stainless steel'}, 'identificationModule': {'nctId': 'NCT04919395', 'briefTitle': 'Preliminary Evaluation of a "Clip" Device for Contraceptive Implant Removal', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Evaluation of a "Clip" Device Added to the Current Standard Removal of Contraceptive Implant to Improve Stability of the Implant, Shorten Removal Time, and Increase the Ease of Removal', 'orgStudyIdInfo': {'id': 'HUM00172715'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clip device removal', 'interventionNames': ['Device: Clip device for Nexplanon Removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care removal', 'interventionNames': ['Procedure: Standard of Care procedure']}], 'interventions': [{'name': 'Clip device for Nexplanon Removal', 'type': 'DEVICE', 'description': 'The clip device will be used to assist in the removal procedure to remove the Nexplanon implant from the subject.', 'armGroupLabels': ['Clip device removal']}, {'name': 'Standard of Care procedure', 'type': 'PROCEDURE', 'description': 'The participants Nexplanon will be removed per standard of care.', 'armGroupLabels': ['Standard of Care removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Carrie Bell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'VentureWell', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Carrie Bell, MD', 'investigatorAffiliation': 'University of Michigan'}}}}