NCT04905511

Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vascudyne, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation.

Detailed description

Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation. Subjects will be followed regularly with office visits at the investigational site at days 15, 29, 57 and weeks 12, 26 for vessel imaging, blood draws and other follow-up tests.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
BIOLOGICAL	natural human collagen arteriovenous graft for hemodialysis access	The True Vascular Graft will be implanted in the forearm or upper arm in a straight or curved configuration.

Timeline

• Start date: 2021-05-10
• Primary completion: 2022-02-15
• Completion: 2022-06-15
• First posted: 2021-05-27
• Last updated: 2022-06-23

Locations

1 site across 1 country: Paraguay

Regulatory

• FDA-regulated drug study