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RECRUITING Phase 2

Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts

NCT04467671 · View on ClinicalTrials.gov ↗

Study Summary

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Interventions

  • COMBINATION_PRODUCT Tissue Engineered Vascular Grafts

Study Locations (1)

Ohio

  • Nationwide Children's Hospital — Columbus

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-07-15
Est. Completion 2027-08
Phase Phase 2

Sponsor

Nationwide Children's Hospital

239 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04467671

The ClinicalTrials.gov registry entry for NCT04467671 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention — of which Tissue Engineered Vascular Grafts is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04467671 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04467671 about?

NCT04467671 is a clinical study titled "Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts". A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

What is the current status of trial NCT04467671?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-07-15. Estimated completion is 2027-08.

What conditions does trial NCT04467671 study?

This clinical trial studies the following conditions: Cardiovascular Diseases, Single-ventricle, Heart Defects, Congenital, Cardiovascular Abnormalities, HLH - Hypoplastic Left Heart Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04467671?

The interventions under investigation include: Tissue Engineered Vascular Grafts (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04467671?

This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04467671 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial