Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-04 @ 11:47 AM
Study NCT ID:
NCT05553418
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2022-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigational On-body Injector Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants will participate in three (3) study arms, whereby each participant will wear six (6) OBI prototype devices in total: three (3) on the arm and three (3) on the abdomen. A randomization scheme will be provided with the order of study arm + body location (arm/abdomen) + body side (left/right) randomized.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2022-07-15', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Performance - Dose delivery efficiency', 'timeFrame': 'After device removal', 'description': 'Determined by volume - measured via gravimetric analysis (weighing the device)'}, {'measure': 'Device Performance', 'timeFrame': 'From device application until 15-minutes after injection', 'description': 'Change in adhesive pad adherence - device to skin/device to adhesive pad - determined via adherence scales (Score 0 - 4, whereby 0 is full adherence and 4 is reflecting full detachment)'}], 'secondaryOutcomes': [{'measure': 'Additional OBI performance - Injection signal/indicator performance', 'timeFrame': 'Before, during and after injection for each applied device; up to 28 hours after application', 'description': 'Assessed by visual or audible observation from activation to injection end.'}, {'measure': 'Additional OBI performance - Catheter condition', 'timeFrame': 'Approximately 15-minutes after device removal', 'description': 'Catheter bending assessment by grading'}, {'measure': 'Participant Pain', 'timeFrame': 'Immediately before device catheter is inserted, after insertion, during wear period, at start of injection, 15 minutes after injection, end of injection and upon removal for each applied device', 'description': '100mm Visual Analog Scale (VAS) for pain assessment - describing no pain with 0mm - up to worst possible pain described with 100mm'}, {'measure': 'Participant Acceptability Questionnaires', 'timeFrame': 'Device acceptability questionnaire will be completed after device catheter is inserted, at 8 hours and 26 hrs after application, during Injection and upon device removal', 'description': "Questionnaires to assess participants' acceptability of the device during wear"}, {'measure': 'Ultrasound Imaging of injection site', 'timeFrame': 'Baseline and immediately after procedure for each applied device', 'description': 'Measure pre- and post-injection tissue thickness'}, {'measure': 'Tissue Effects', 'timeFrame': 'Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present', 'description': 'Assessment of wheal and erythema described via grading 0-4, incidence of bleeding, bruising, induration'}, {'measure': 'Adverse Events', 'timeFrame': 'Throughout study completion, an average of 4 week', 'description': 'Incidence of adverse device effects and procedure related adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['On-Body Injector'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.', 'detailedDescription': 'This study is a monocentric, open-label, cross-over, feasibility and exploratory study with no acceptance criteria. Up to 70 healthy volunteers will be enrolled and followed up for 7 weeks at maximum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult participants ≥ 18 years\n* BMI ≥18.5 kg/m2\n* Participant willing and able to complete all required study procedures and to provide informed consent\n\nExclusion Criteria:\n\n* Participant any self-reported existing chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.).\n* Participants with treatment interfering with coagulation, platelet function, or pain perception within 12 hrs of in-clinic visit\n* Participants with abdominal or arm skin conditions or treatments that may interfere with planned study treatment\n* Participants with acute or chronic hepatitis B or C and/or with known history/positive HIV serology.\n* Participants who are pregnant, planning to become pregnant, or are breast-feeding.'}, 'identificationModule': {'nctId': 'NCT05553418', 'briefTitle': 'Investigational On-body Injector Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Becton, Dickinson and Company'}, 'officialTitle': 'BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm', 'orgStudyIdInfo': {'id': 'PHS-20OBI01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"In-Clinic wear first"', 'description': 'Participant will wear the devices first during 27 hr in-clinic wear first followed by injection, then a short-term wear period in-clinic followed by injection, and finally at home for 27 hrs followed by injection.', 'interventionNames': ['Device: In-clinic wear first']}, {'type': 'EXPERIMENTAL', 'label': '"Home wear first"', 'description': 'Participant will wear the devices at home first with return to clinic for injection, followed by a short-term wear period in-clinic for injection, and finally during a 27hr in-clinic stay for injection', 'interventionNames': ['Device: Home wear first']}], 'interventions': [{'name': 'In-clinic wear first', 'type': 'DEVICE', 'description': 'Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection', 'armGroupLabels': ['"In-Clinic wear first"']}, {'name': 'Home wear first', 'type': 'DEVICE', 'description': 'Device will be applied to the abdomen or arm to deliver placebo subcutaneously. After device application, participant will go home and return to clinic before delivery.', 'armGroupLabels': ['"Home wear first"']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gières', 'country': 'France', 'facility': 'Eurofins Optimed', 'geoPoint': {'lat': 45.17997, 'lon': 5.78935}}], 'overallOfficials': [{'name': 'Yves Donazzolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurofins'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}