MedTrace Logo

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

NCT04905511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-06-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Vascudyne, Inc.

    lead INDUSTRY

Principal Investigators

  • Adrian Ebner, MD · Sanatorio Italiano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2022-02-15
Completion
2022-06-15
FDA Drug
Yes

Countries

  • Paraguay

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04905511 on ClinicalTrials.gov