NCT04709341

Transradial-Band Pilot Study

Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the study group, the TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals. In the standard of care group, the TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals. The aim of the study is to reduce the time the device is in place while minimizing potential complications.

Conditions

• Radial Artery Incision Site Closure

Interventions

Type	Name	Description
DEVICE	TR Band 60MIN	TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
DEVICE	TR Band 120MIN	TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals

Timeline

• Start date: 2021-02-03
• Primary completion: 2024-02-01
• Completion: 2024-02-20
• First posted: 2021-01-14
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study