Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04131920
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2019-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Handheld Ultrasound (HHUS) for Home Use in Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006395', 'term': 'Hemarthrosis'}, {'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2019-10-14', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers.', 'timeFrame': '3 months', 'description': 'Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test.'}, {'measure': 'Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle.', 'timeFrame': '3 months', 'description': 'Number of participating subjects who are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle based on post-training test.'}, {'measure': 'Outcome 1.3: Participating subjects can perform what they learned during their training at the HTC in outcome 1.1 and outcome 1.2 at home and transmit images to the HTC.', 'timeFrame': '3 months', 'description': 'Number of participating subjects who can perform what they learned during their training at the HTC in outcome 1.1 and outcome 1.2 at home and transmit images to the HTC on post-training test.'}, {'measure': 'Outcome 2.1: Subjects will be able to attain and transmit images of their joint spaces to the HTC via telemedicine utilizing the HHUS technology they learned in phase 1 and React App.', 'timeFrame': '6 months', 'description': 'Number of subjects who will be able to attain and transmit images of their joint spaces to the HTC via telemedicine utilizing the HHUS technology they learned in phase 1 and React App.'}, {'measure': 'Outcome 2.2: Accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.', 'timeFrame': '6 months', 'description': 'Percentage accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.'}, {'measure': 'Outcome 3.1: To establish how accurate patient reported bleeding is compared to HHUS utilizing tele-ultrasound.', 'timeFrame': '3 years', 'description': 'Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound.'}, {'measure': 'Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study.', 'timeFrame': '3 years', 'description': 'Number of patients who have joint bleeding data incorporated into the EmiMSKUS study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Joint Bleed', 'Hemophilia A', 'Handheld Ultrasound'], 'conditions': ['Joint Bleed', 'Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '22757683', 'type': 'BACKGROUND', 'citation': 'Forsyth AL, Giangrande P, Hay CR, Kenet G, Kessler CM, Knobl PN, Llinas A, Santagostino E, Young G. Difficult clinical challenges in haemophilia: international experiential perspectives. Haemophilia. 2012 Jul;18 Suppl 5:39-45. doi: 10.1111/j.1365-2516.2012.02887.x.'}, {'pmid': '17687129', 'type': 'BACKGROUND', 'citation': 'Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, Ingram JD, Manco-Johnson ML, Funk S, Jacobson L, Valentino LA, Hoots WK, Buchanan GR, DiMichele D, Recht M, Brown D, Leissinger C, Bleak S, Cohen A, Mathew P, Matsunaga A, Medeiros D, Nugent D, Thomas GA, Thompson AA, McRedmond K, Soucie JM, Austin H, Evatt BL. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007 Aug 9;357(6):535-44. doi: 10.1056/NEJMoa067659.'}, {'pmid': '17723130', 'type': 'BACKGROUND', 'citation': 'Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. doi: 10.1111/j.1538-7836.2007.02663.x.'}, {'pmid': '22047559', 'type': 'BACKGROUND', 'citation': 'Leissinger C, Gringeri A, Antmen B, Berntorp E, Biasoli C, Carpenter S, Cortesi P, Jo H, Kavakli K, Lassila R, Morfini M, Negrier C, Rocino A, Schramm W, Serban M, Uscatescu MV, Windyga J, Zulfikar B, Mantovani L. Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors. N Engl J Med. 2011 Nov 3;365(18):1684-92. doi: 10.1056/NEJMoa1104435.'}, {'pmid': '28691557', 'type': 'BACKGROUND', 'citation': 'Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. doi: 10.1056/NEJMoa1703068. Epub 2017 Jul 10.'}, {'type': 'BACKGROUND', 'citation': 'Mahlangu et al. Emicizumab prophylaxis administered once-weekly or every two weeks provides effective bleed prevention in persons with haemophilia A without inhibitors - Results from the phase III HAVEN 3 study . Oral presented at the World Federation of Hemophilia Meeting in Glasgow, May 21, 2018.'}, {'pmid': '23672827', 'type': 'BACKGROUND', 'citation': 'Ceponis A, Wong-Sefidan I, Glass CS, von Drygalski A. Rapid musculoskeletal ultrasound for painful episodes in adult haemophilia patients. Haemophilia. 2013 Sep;19(5):790-8. doi: 10.1111/hae.12175. Epub 2013 May 15.'}, {'pmid': '29436079', 'type': 'BACKGROUND', 'citation': 'Zhou JY, Rappazzo KC, Volland L, Barnes RFW, Brackman M, Steiner B, Kruse-Jarres R, Quon DV, Bailey C, Chang EY, von Drygalski A. Pocket handheld ultrasound for evaluation of the bleeding haemophilic joint: A novel and reliable way to recognize joint effusions. Haemophilia. 2018 Mar;24(2):e77-e80. doi: 10.1111/hae.13429. Epub 2018 Feb 12. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "This is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (HHUS) in a patient's home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not.", 'detailedDescription': 'This is a study in 3 phases that will assess the feasibility and utility of handheld home ultrasound (HHUS) in a patient\'s home to assess whether a painful episode in the elbow, knee or ankle is a bleed or not.\n\nPhase 1 will assess whether 10 subjects with severe hemophilia A can be trained to use HHUS in clinic to identify basic joint structures of the elbow, knee and ankle. It will then assess whether these subjects can identify these structures at home and transmit the images life via tele-ultrasound.\n\nPhase 2 will assess whether the determination of "bleed" vs. "non-bleed" made at home via HHUS can be confirmed/validated with a standard high resolution ultrasound machine in clinic.\n\nPhase 3 will then utilize HHUS during the EmiMSKUS study over 3 years to more objectively identify patient reported bleeding during the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males patients at Hemophilia Treatment Centers with severe Hemophilia A', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe hemophilia A\n* Male\n* Over 18 years of age\n* Able to read, write and understand English\n* Willing to come to the center for an 8 hour training session\n* Lives in proximity of the HTC and is willing to come in for acute joint episodes in phase 2\n* Willing and able to follow study procedures\n* Willing and able to keep HHUS at a safe place\n* Have the dexterity to operate a HHUS unit\n\nExclusion Criteria:\n\n* Unable to follow study instructions\n* Physically or mentally unable to operate a HHUS unit'}, 'identificationModule': {'nctId': 'NCT04131920', 'acronym': 'HHUS', 'briefTitle': 'Handheld Ultrasound (HHUS) for Home Use in Hemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Washington Institute for Coagulation'}, 'officialTitle': 'Handheld Ultrasound (HHUS) for Home Use in Hemophilia', 'orgStudyIdInfo': {'id': 'ML41066'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1 and 2', 'description': '10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders', 'interventionNames': ['Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform']}, {'label': 'Phase 3', 'description': '20 subjects who are also participating in the EmiMSKUS study', 'interventionNames': ['Device: handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform']}], 'interventions': [{'name': 'handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform', 'type': 'DEVICE', 'description': 'Patients receive training by the physical therapist to operate a handheld ultrasound (HHUS) including proper probe placement. Subjects will be tested on their knowledge at the HTC to demonstrate proficiency, and will then repeat the testing at home via tele-ultrasound.', 'armGroupLabels': ['Phase 1 and 2', 'Phase 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Washington Center for Bleeding Disorders at Washington Institute for Coagulation', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Rebecca Kruse-Jarres, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington Institute for Coagulation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington Institute for Coagulation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive/Medical Director, Washington Center for Bleeding Disorders', 'investigatorFullName': 'Rebecca Kruse-Jarres, MD, MPH', 'investigatorAffiliation': 'Washington Institute for Coagulation'}}}}