Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-02 @ 4:25 PM
Study NCT ID:
NCT05221333
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2021-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorrel 25R Injector - Sorrel Clinical Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075662', 'term': 'Injection Site Reaction'}], 'ancestors': [{'id': 'D005119', 'term': 'Extravasation of Diagnostic and Therapeutic Materials'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a single group of health participants'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-20', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2022-01-20', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall experience of SWI', 'timeFrame': '24 hours', 'description': 'Assessment of overall experience based on patient questionnaire'}], 'primaryOutcomes': [{'measure': 'Reliability of SWI', 'timeFrame': '24 hours', 'description': '70% successful injection confirmed by visual inspection of investigator'}], 'secondaryOutcomes': [{'measure': 'Incidences of Treatment Emergent Adverse Events of SWI', 'timeFrame': '1 month', 'description': 'Evaluation of AEs'}, {'measure': 'Pain associated with use of SWI', 'timeFrame': '1 month', 'description': 'Pain assessment based on visual analog scale (VAS), higher score means worse outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['wearable injector'], 'conditions': ['Injection Site', 'Injection Site Reaction', 'Injection Site Irritation']}, 'descriptionModule': {'briefSummary': 'A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.', 'detailedDescription': 'A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.\n\nThe study will enroll up to 25 healthy adult subjects. Each subject will perform a maximum of 5 visits during the study over a period of approximately 2 months; a virtual visit for informed consent, two in-person visits for device evaluation, and two follow-up virtual visits to evaluate the skin and surrounding tissue for adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 to ≤ 40 years.\n\nSubject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent.\n\nSubject has no active signs/symptoms of a viral infection for 10 days prior to visit # 2.\n\nBody Mass Index between 20 to 35 kg/m2 (inclusive).\n\nSubject willing and able to comply with study procedures.\n\nAmerican Society of Anaesthesiology Physical status (ASA PS) classification 1\n\nExclusion Criteria:\n\nCurrent use of aspirin at a daily dose \\> 81 mg,\n\nCurrent use of any medication that may adversely affect blood coagulation (i.e. warfarin, Xarelto, Eliquis etc.)\n\nPresence of any tattoos, discoloration, acne, scars, bruises, cuts, abrasions, rashes, hernias, or inflammation within the skin or subcutaneous tissue of the abdomen that could interfere with the infusion of saline or observation of study results, at the discretion of the investigator..\n\nHistory of significant skin allergy, irritation, or hypersensitivity to medical adhesives or adhesive tape.\n\nHistory of significant allergic reaction to medical saline solution.\n\nHistory of significant allergic reaction to the skin antiseptic solutions alcohol or chlorhexidine.\n\nHistory of any neurologic disease that may affect the perception of pain/discomfort (stroke, peripheral neuropathy).\n\nCurrent use of any medication that may affect the perception of pain/discomfort (opioids, NSAIDs, topical local anesthetics) at the discretion of the investigator.\n\nCurrent use of any medical condition or medication that to the opinion of the investigator may affect the risk for a serious adverse event\n\nFemale of childbearing age with a positive pregnant test, or currently breast feeding.\n\nStudy subject refuses to allow clipping of excess abdominal hair at the site of device placement\n\nAny current or unstable cardiac, pulmonary, hepatic, renal, neurologic, gastrointestinal, endocrine, immune, endocrine, musculoskeletal, coagulation disorder, or infectious disease which in the opinion of the Investigator would place the subject at risk or influence the conduct of the study, or interpretation of the results.\n\nCurrent participation in another clinical drug or device study.\n\nInability of the subject to comply with all study procedures.\n\nInability of the subject to understand the information required for monitoring their infusion sites.'}, 'identificationModule': {'nctId': 'NCT05221333', 'briefTitle': 'Sorrel 25R Injector - Sorrel Clinical Study Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eitan Medical'}, 'officialTitle': 'Assessment of Safety and Performance of an Investigational Wearable Injector in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'VAL-15144-0005662'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy participants', 'description': 'Up to 25ml of saline administered through OBI', 'interventionNames': ['Device: Sorrel Wearable Injector']}], 'interventions': [{'name': 'Sorrel Wearable Injector', 'type': 'DEVICE', 'description': 'Use of Sorrel Wearable Injector in pilot study', 'armGroupLabels': ['Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc C Torjman, Ph.D', 'role': 'CONTACT', 'email': 'marc.torjman@jefferson.edu', 'phone': '215-955-6161'}, {'name': 'Jennifer Lessin, RN', 'role': 'CONTACT', 'email': 'jennifer.lessin@jefferson.edu', 'phone': '2159555804'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Marc C Torjman, Ph.D.', 'role': 'CONTACT', 'email': 'marc.torjman@jefferson.edu', 'phone': '215-955-6161'}, {'name': 'Jennifer Lessin, RN', 'role': 'CONTACT', 'email': 'jennifer.lessin@jefferson.edu', 'phone': '215-955-5804'}], 'overallOfficials': [{'name': 'Marc C Torjman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a pilot study for internal use only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eitan Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Thomas Jefferson University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}