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ACTIVE NOT RECRUITING NA

Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns

NCT04090424 · View on ClinicalTrials.gov ↗

Study Summary

This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).

Conditions Studied

Interventions

  • PROCEDURE Standard of Care
  • DEVICE NovoSorb BTM

Study Locations (20)

California

  • Southern California Regional Burn Center at LAC+USC — Los Angeles
  • University of California Davis Medical Center — Sacramento

Massachusetts

  • Brigham and Women's Hospital — Boston
  • Massachusetts General Hospital — Boston

North Carolina

  • University of North Carolina at Chapel Hill — Chapel Hill
  • Wake Forest Baptist Health — Winston-Salem

Ohio

  • Akron Children's Hospital, Burn Center — Akron
  • The Ohio State University/ Wexner Medical Center — Columbus

Pennsylvania

  • Lehigh Valley Hospital and Health Network — Allentown
  • Temple University Hospital — Philadelphia

Arizona

  • Valleywise Health — Phoenix

Connecticut

  • Bridgeport Hospital — Bridgeport

District of Columbia

  • MedStar Washington Hospital Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2021-09-21
Est. Completion 2026-12
Phase NA

Sponsor

PolyNovo Biomaterials Pty

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04090424

The ClinicalTrials.gov registry entry for NCT04090424 describes a study currently listed as active not recruiting. It is categorized as NA, 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 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PolyNovo Biomaterials Pty, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Burns appearing as the primary indexed condition, and to 2 interventions — of which Standard of Care 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: NCT04090424 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Massachusetts, North Carolina. 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 NCT04090424 about?

NCT04090424 is a clinical study titled "Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns". This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).

What is the current status of trial NCT04090424?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-09-21. Estimated completion is 2026-12.

What conditions does trial NCT04090424 study?

This clinical trial studies the following conditions: Burns. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04090424?

The interventions under investigation include: Standard of Care (PROCEDURE), NovoSorb BTM (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04090424?

This trial is sponsored by PolyNovo Biomaterials Pty, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04090424 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. 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