Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-26 @ 7:48 PM
Study NCT ID:
NCT01994434
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ulnar Nerve Deep Branch Compression by a Ganglion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009463', 'term': 'Neuroma'}], 'ancestors': [{'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grip strength', 'timeFrame': '18-24 months', 'description': 'Grip strength is measured using the E-LINK system.'}, {'measure': 'Tip pinch strength', 'timeFrame': '18-24 months', 'description': 'Tip pinch strength between the thumb and index finger is measured using the E-LINK system.'}], 'secondaryOutcomes': [{'measure': "Modified Bishop's scoring system", 'timeFrame': '18-24 months', 'description': "According Bishop's scoring system, we redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Deep branch of the ulnar nerve', 'Distal ulnar nerve compression'], 'conditions': ["Guyon's Canal", 'Nerve Compression']}, 'referencesModule': {'references': [{'pmid': '20513615', 'type': 'RESULT', 'citation': 'Almeida V, de Carvalho M. Lesion of the deep palmar branch of the ulnar nerve: causes and clinical outcome. Neurophysiol Clin. 2010 Jun;40(3):159-64. doi: 10.1016/j.neucli.2010.01.005. Epub 2010 Feb 17.'}]}, 'descriptionModule': {'briefSummary': "Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of this study are to report a series of 9 patients with pure ulnar nerve deep branch compression by a ganglion and to evaluate the outcome following a surgical treatment. According modified Bishop's scoring system, the investigators would evaluate postoperative results of this uncommon nerve lesion.", 'detailedDescription': "Pre- and post-operative physical examination include assessment of tenderness and strength (grip and pinch). Grip strength and tip pinch strength between the thumb and index finger are measured using the E-LINK system. According Bishop's scoring system, the investigators redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUlnar nerve deep branch compression by a ganglion -\n\nExclusion Criteria:\n\nUlnar nerve deep branch compression caused by other reasons\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01994434', 'briefTitle': 'Ulnar Nerve Deep Branch Compression by a Ganglion', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Tangshan'}, 'orgStudyIdInfo': {'id': 'TSWang9804'}, 'secondaryIdInfos': [{'id': 'HEBEI-J0821', 'type': 'OTHER', 'domain': 'Hebei Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Decompression of the ulnar nerve', 'description': "Surgical decompression of the Guyon's canal and ganglion excision", 'interventionNames': ['Procedure: Decompression of the ulnar nerve']}], 'interventions': [{'name': 'Decompression of the ulnar nerve', 'type': 'PROCEDURE', 'description': "Surgical decompression of the Guyon's canal and ganglion excision", 'armGroupLabels': ['Decompression of the ulnar nerve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '063000', 'city': 'Tangshan', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Tangshan', 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Tangshan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}