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Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study)

NCT05567757 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-07-03

No results posted yet for this study

Summary

Prospective, nonrandomized, single-arm, single-center, open-label, initial safety study in subjects requiring hemodialysis. Subjects will be followed with physical evaluation and ultrasound vessel imaging at days 15, 29, 57 and weeks 12, 26. Extended follow up on patent conduits only at weeks 52 and 104.

Conditions

Interventions

BIOLOGICAL

Arteriovenous conduit implant

Study subjects will be implanted with an arteriovenous shunt for hemodialysis access in the upper extremity

Sponsors & Collaborators

  • Vascudyne, Inc.

    lead INDUSTRY

Principal Investigators

  • Ernesto Alvarado, MD · Centro de Asistencia Renal, Río Hato, Coclé, Panamá

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2025-03-30
Completion
2025-03-30
FDA Drug
Yes

Countries

  • Panama

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 NCT05567757 on ClinicalTrials.gov