Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05590494
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Treatment for Rotator Cuff Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'Baseline, 2, 6, 12 and 24-weeks post-procedure', 'description': 'Measured using a visual analog scale (VAS), used to measure subjective pain, rated from 0 (no pain) to 100 (most severe pain) at rest and during activity (previously painful activities)'}, {'measure': 'Change in shoulder active range of motion', 'timeFrame': 'Baseline, 2, 6, 12 and 24-weeks post-procedure', 'description': 'Measured using a goniometer reported in degrees'}, {'measure': 'Change in shoulder strength', 'timeFrame': 'Baseline, 2, 6, 12 and 24-weeks post-procedure', 'description': 'Assessed using a hand-held dynamometer (HHD) placed distally on the forearm, just proximal to the wrist joint along the distal radius and ulna with instruction to push into the HHD with maximum force production for approximately 5 seconds.'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life', 'timeFrame': 'Baseline, 2, 6, 12 and 24-weeks post-procedure', 'description': 'Measured using the SF-36 Quality of Life questionnaire which is a 36-item self-reported health survey that measures health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasonic tenotomy'], 'conditions': ['Supraspinatus Tear']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (\\<50%) of the supraspinatus tendon of the rotator cuff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Evidence of partial tear (\\< 50%) of the supraspinatus tendon on MRI.\n\nExclusion Criteria:\n\n* A tear of the supraspinatus tendon greater \\> 50% and any areas of full thickness tearing, concomitant tears \\> 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum.\n* Evidence of systemic illness/infection requiring oral or IV antibiotics during the recruitment period.\n* Evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder.\n* Previous corticosteroid injection within three months.\n* Those individuals less than 25 and greater than 75 years of age will be excluded.'}, 'identificationModule': {'nctId': 'NCT05590494', 'briefTitle': 'Novel Treatment for Rotator Cuff Tears', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study', 'orgStudyIdInfo': {'id': '21-011522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Repair a partially torn rotator cuff', 'description': 'Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated', 'interventionNames': ['Procedure: Ultrasonic tenotomy']}], 'interventions': [{'name': 'Ultrasonic tenotomy', 'type': 'PROCEDURE', 'description': 'Ultrasonic procedure as part of standard of care, as clinically indicated, to stimulate healing of the partial tear. The procedure uses ultrasound guidance that allows a needlelike device to gradually break up and remove tendinopathic tendon tissue.', 'armGroupLabels': ['Repair a partially torn rotator cuff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54650', 'city': 'Onalaska', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacob Erickson, DO', 'role': 'CONTACT', 'email': 'erickson.jacob@mayo.edu', 'phone': '608-392-9876'}], 'facility': 'Mayo Clinic Health System - Onalaska', 'geoPoint': {'lat': 43.88441, 'lon': -91.23514}}], 'overallOfficials': [{'name': 'Jacob Erickson, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jacob L. Erickson', 'investigatorAffiliation': 'Mayo Clinic'}}}}