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Completed

NCT Number: NCT04131920

Handheld Ultrasound (HHUS) for Home Use in Hemophilia

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.

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Key information

Conditions

Joint Bleed Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemarthrosis Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhage Hemorrhagic Disorders Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Washington Center for Bleeding Disorders at Washington Institute for Coagulation

Seattle, Washington, 98101, United States

About this study

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.

Phase 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.

Phase 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.

Phase 3 will then utilize HHUS during the EmiMSKUS study over 3 years to more objectively identify patient reported bleeding during the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe hemophilia A
  • Male
  • Over 18 years of age
  • Able to read, write and understand English
  • Willing to come to the center for an 8 hour training session
  • Lives in proximity of the HTC and is willing to come in for acute joint episodes in phase 2
  • Willing and able to follow study procedures
  • Willing and able to keep HHUS at a safe place
  • Have the dexterity to operate a HHUS unit

Exclusion criteria

  • Unable to follow study instructions
  • Physically or mentally unable to operate a HHUS unit

Treatment and study plan

handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform

Device

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.

Primary outcomes

  1. Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers.

    Time frame: 3 months

    Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test.

  2. Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle.

    Time frame: 3 months

    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.

  3. 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.

    Time frame: 3 months

    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.

  4. 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.

    Time frame: 6 months

    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.

  5. 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.

    Time frame: 6 months

    Percentage accuracy of the assignment of "bleed" vs. "non-bleed" will be determined on the stationary GE LS8 Logiq Pro in the HTC.

  6. Outcome 3.1: To establish how accurate patient reported bleeding is compared to HHUS utilizing tele-ultrasound.

    Time frame: 3 years

    Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound.

  7. Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study.

    Time frame: 3 years

    Number of patients who have joint bleeding data incorporated into the EmiMSKUS study.

Sponsors and collaborators

Lead sponsor

Washington Institute for Coagulation

Other

Collaborators

  • Genentech, Inc.

Registry information

Acronym: HHUS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2019
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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