Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT04131920
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:
NCT04131920
Study Brief:
Protocol Section:
NCT04131920