Handheld Ultrasound (HHUS) for Home Use in Hemophilia

Washington Institute for Coagulation

Status: Completed

Conditions: Joint Bleed; Hemophilia A

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04131920

ML41066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Phase 1 and 2

Description:

10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders

Treatment:

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

Phase 3

Description:

20 subjects who are also participating in the EmiMSKUS study

Treatment:

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