Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-28 @ 10:34 PM
Study NCT ID:
NCT03840434
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003161', 'term': 'Compartment Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-02-12', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of MyotonPRO', 'timeFrame': '3 years', 'description': 'To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg'}], 'secondaryOutcomes': [{'measure': 'Diagnostic performance of MyotonPRO at 1 minute post-exercise', 'timeFrame': '3 years', 'description': 'To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.'}, {'measure': 'Diagnostic performance of MyotonPRO at 5 minute post-exercise', 'timeFrame': '3 years', 'description': 'To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['compartment syndrome', 'intramuscular punction Versus non invasive assessment'], 'conditions': ['Compartment Syndrome']}, 'descriptionModule': {'briefSummary': 'Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed.\n\nCurrently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS.\n\nOther less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.', 'detailedDescription': 'Patients referred for suspected chronic compartment syndrome causing will be included.\n\nAfter signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliation to the French National healthcare system\n* French speaking patients\n* Referred for investigation of compartment syndrome causing\n\nExclusion Criteria:\n\n* Pregnancy\n* Inability to understand the study goal\n* Patients protected by decision of law\n* Extended dermatosis\n* Coagulation disorder'}, 'identificationModule': {'nctId': 'NCT03840434', 'acronym': 'COLONIA', 'briefTitle': 'COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)', 'orgStudyIdInfo': {'id': '2019-A00141-56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CCS group', 'description': 'Measurements by intramuscular punction and non invasive tool', 'interventionNames': ['Diagnostic Test: MyotonPRO']}], 'interventions': [{'name': 'MyotonPRO', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO', 'armGroupLabels': ['CCS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'Centre hospitalier universitaire', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Antoine BRUNEAU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}