Handheld Ultrasound (HHUS) for Home Use in Hemophilia

Completed

• Conditions: Joint Bleed; Hemophilia A

• Registration Number: NCT04131920
• Lead Sponsor: Washington Institute for Coagulation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Status Verified: 2022-06
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.
Outcome 3.1: To establish how accurate patient reported bleeding is compared to HHUS utilizing tele-ultrasound.	3 years	Percentage accuracy of patient reported bleeding is compared to HHUS utilizing tele-ultrasound.
Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers.	3 months	Number of participating subjects who understand basic ultrasound transducer concepts and can perform basic positioning maneuvers based on post-training test.
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.	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.
Outcome 3.2: To establish more accurate bleeding data for the EmiMSKUS study.	3 years	Number of patients who have joint bleeding data incorporated into the EmiMSKUS study.
Outcome 1.2: Participating subjects are able to perform basic transducer positions and identify basic structures of the elbow, knee and ankle.	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.
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.	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.

Trial Locations

Locations (1)

Washington Center for Bleeding Disorders at Washington Institute for Coagulation; 🇺🇸 Seattle, Washington, United States