Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05332405
Status:
WITHDRAWN
Last Update Posted:
2023-06-29
First Post:
2022-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020430', 'term': 'Cubital Tunnel Syndrome'}], 'ancestors': [{'id': 'D020424', 'term': 'Ulnar Neuropathies'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017769', 'term': 'Ulnar Nerve Compression Syndromes'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Obsolete study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in level of Fluorescence before and after nerve release.', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits', 'description': 'Assessed by comparing the SPY angiography value before and after nerve release surgery'}], 'secondaryOutcomes': [{'measure': 'nerve function determined by grip strength', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits', 'description': 'Assessed by comparing the value of grip strength at each follow-up visits to the value of grip strength before nerve release surgery'}, {'measure': 'Change in Monofilament sensory testing', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits', 'description': 'Assessed by comparing the Monofilament sensory testing score at each follow-up visit to the Monofilament sensory testing score before nerve release surgery'}, {'measure': 'Change in DASH Score', 'timeFrame': '2 weeks, 6 weeks, 3 months, 6 months, and 12 months visits', 'description': 'DASH score at each follow-up visit does not differ from that before nerve release surgery. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on the test ranges is from 0 (no disability) to 100 (most severe disability).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cubital Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients with vascular disease, thyroid disease or an allergy to indocyanine green (ICG) will be excluded. Patients with either median or ulnar nerve compression will be treated with nerve decompression. SPY angiography will be used to assess the vascularity of the nerve both pre and post release as the primary outcome measure.', 'detailedDescription': 'The purpose of this study is to use laser imaging to determine the extent of nerve decompression (release) while patients are still in surgery. Commonly, this is determined by electrodiagnostic tests or physical examination. The researchers will use the SPY elite device along with an injection of a drug called SPY Agent green (indocyanine green) in an imaging procedure called fluorescence angiography to visualize the change in blood supply to the nerve, following the nerve decompression surgery and assess if SPY is a useful tool for evaluating the success of nerve decompression surgery. The use of fluorescence angiography with the SPY elite device and SPY agent green is Food and Drug Administration (FDA) approved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older; male and female patients\n* Ulnar Nerve Compression at the Elbow\n* Failed conservative treatment (i.e. hand therapy, pain medications, splinting)\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy/breastfeeding\n* Thyroid Disease\n* Vascular Disease\n* Known allergy to any study drug'}, 'identificationModule': {'nctId': 'NCT05332405', 'briefTitle': 'SPY Angiography To Assist With Ulnar Nerve Transposition at the Elbow', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'SPY Angiography To Determine the Extent of Nerve Release After Nerve Decompression', 'orgStudyIdInfo': {'id': '21-01449'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Participants will have planned surgical procedure to repair the median or ulnar nerve compression. During the procedure, the doctor will administer a small injection of indocyanine green (ICG) and laser angiography using the SPY Elite device will be used to evaluate blood flow and extent of nerve decompression at the surgical site. Participation will also involve filling out two questionnaires on pain and function level and an examination of hand strength and range of motion.', 'interventionNames': ['Drug: Indocyanine green']}], 'interventions': [{'name': 'Indocyanine green', 'type': 'DRUG', 'otherNames': ['SPY AGENT GREEN'], 'description': 'The subject will receive 3mL of ICG followed by 10 mL of sterile saline intravenously as per the Spy Elite protocol. Within minutes of the injection, the SPY machine will be turned on and focused on the nerve. The SPY machine gives a digital read out of the % fluorescence when the dye reaches the nerve. This number correlates with blood flow or vascularity.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jacques Hacquebord, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will only be used for this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}