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NCT01840956 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

A Phase 1 study, sponsored by Humacyte.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01840956: Completed Phase 1 study, sponsored by Humacyte.

NCT01840956 is a Phase 1 study that has completed, run by Humacyte. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01840956, a Phase 1 study, has completed, sponsored by Humacyte.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG. The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.

Primary Outcome

The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be assessed by Doppler ultrasound and tabulated.

Interventions

  • BIOLOGICAL HAVG

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2013-05-23
Est. Completion 2016-04-28
Phase Phase 1
Humacyte

6 total trials

What the finished NCT01840956 record still lists

NCT01840956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which HAVG is the first listed.

NCT01840956 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01840956 about?

NCT01840956 is a clinical study titled "Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease". The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG. The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.

What is the current status of trial NCT01840956?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-05-23. Estimated completion is 2016-04-28.

What interventions are being tested in trial NCT01840956?

The interventions under investigation include: HAVG (BIOLOGICAL).

Who is sponsoring clinical trial NCT01840956?

This trial is sponsored by Humacyte, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01840956's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01840956, the US trial registry maintained by the National Library of Medicine. NCT01840956 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.