Brief Title
Handheld Ultrasound (HHUS) for Home Use in Hemophilia
Official Title
Handheld Ultrasound (HHUS) for Home Use in Hemophilia
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 Type
Observational
Primary Outcome
Outcome 1.1: Participant understanding of basic ultrasound transducer concepts and ability to perform basic positioning maneuvers.
Condition
Joint Bleed
Intervention
handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform
Study Arms / Comparison Groups
Phase 1 and 2
Description: 10 male patients with severe Hemophilia A from the Washington Center for Bleeding Disorders
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
10
Start Date
October 1, 2019
Completion Date
June 22, 2022
Primary Completion Date
June 22, 2022
Eligibility Criteria
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
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rebecca Kruse-Jarres, MD, MPH, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04131920
Organization ID
ML41066
Responsible Party
Principal Investigator
Study Sponsor
Washington Institute for Coagulation
Collaborators
Genentech, Inc.
Study Sponsor
Rebecca Kruse-Jarres, MD, MPH, Principal Investigator, Washington Institute for Coagulation
Verification Date
June 2022