Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 7:16 AM
Study NCT ID:
NCT06441903
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connective Tissue of Pectoralis Major Muscle: Anatomical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound visualization of Delto Pectoral Tendon', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Measurement of DPT by ultrasonography (height, length and thickness in mm)', 'timeFrame': 'Day 1'}, {'measure': 'Measurement of ADT by ultrasonography (height, length and thickness in mm)', 'timeFrame': 'Day 1'}, {'measure': 'Measurement of PMT by ultrasonography (height, length and thickness in mm)', 'timeFrame': 'Day 1'}, {'measure': 'Measurement of the distances in mm between the PMT humeral insertion and the different connective structures: ADT, DPT, ALPM, PLPM and DFPM', 'timeFrame': 'Day 1'}, {'measure': 'Ultrasound visualization of the clavicular and sternal portions of the pectoralis major.', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Deltoid Tendon', 'Anterior Lamina Pectoralis Major', 'Posterior Lamina Pectoralis Major', 'Pectoralis Major Tendon', 'Ultrasound', 'Deep Fascia Pectoralis Major', 'Delto Pectoral Tendon'], 'conditions': ['Tendon Injury - Upper Limb']}, 'descriptionModule': {'briefSummary': 'The delto-pectoral tendon (DPT) is a new tendon recently identified. It completes the insertion of the pectoralis major and perfectly explains the different injuries encountered.\n\nThe objective of this observational study is to visualize this new tendon, the DPT, using ultrasound, to measure it, to characterize its role in the overall architecture of the pectoralis major muscle and to analyze its relationship with its main tendon and the anterior and posterior laminae.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with no history of pectoralis major and consulting for a musculoskeletal pathology of the upper limb', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient \\> 18 years,\n* Consultation for a musculoskeletal pathology of the upper limb\n\nExclusion Criteria:\n\n* History of pathology of the pectoralis major or of the distal tendon of the pectoralis major\n* Pregnant or breastfeeding women\n* Patient under protection of the adults (guardianship, curators or safeguard of justice)\n* Unable to understand\n* Opposition by the patient'}, 'identificationModule': {'nctId': 'NCT06441903', 'acronym': 'USPEC', 'briefTitle': 'Connective Tissue of Pectoralis Major Muscle: Anatomical Study', 'organization': {'class': 'OTHER', 'fullName': 'CMC Ambroise Paré'}, 'officialTitle': 'Connective Tissue of Pectoralis Major Muscle: Anatomical Study', 'orgStudyIdInfo': {'id': '2024/02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with no history of pectoralis major', 'interventionNames': ['Other: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'OTHER', 'otherNames': ['Shoulder ultrasound with focus on pectoralis major muscle connective skeleton and distal tendon'], 'description': 'Through systematic ultrasound visualization of the pectoralis major muscle, we seek to directly visualize and characterize the different intra- and extra-muscular connective structures of the muscle - Delto Pectoral Tendon (DPT) , Distal Pectoralis Major Tendon (PMT), Anterior Deltoid Tendon (ADT), Anterior Pretendinous Lamina of the Pectoralis Major (ALPM), Posterior Pretendinous Lamina of the Pectoralis Major (PLPM) and Deep Fascia of the Pectoral Major (DFPM) - constituting its connective skeleton, with particular attention to its distal portion near the humerus and on the search for this DPT tendon.', 'armGroupLabels': ['Adults with no history of pectoralis major']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Ambroise Paré - Hartmann Private Hospital Group', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMC Ambroise Paré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}