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RECRUITING Phase 2

Hyperbaric Oxygen Brain Injury Treatment Trial

NCT02407028 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

Conditions Studied

Interventions

  • DRUG Hyperbaric oxygen (1.5 ATA, no NBH)
  • DRUG Hyperbaric oxygen (2.0 ATA, no NBH)
  • DRUG Hyperbaric oxygen (2.5 ATA, no NBH)
  • DRUG Hyperbaric oxygen (1.5 ATA + NBH)
  • DRUG Hyperbaric oxygen (2.0 ATA + NBH)

Study Locations (11)

California

  • UCSD Medical Center - Hillcrest Hospital — San Diego

Florida

  • St. Mary's Medical Center — West Palm Beach

Iowa

  • University of Iowa Hospitals and Clinics — Iowa City

Kentucky

  • University of Kentucky Hospital — Lexington

Maryland

  • University of Maryland — Baltimore

Michigan

  • Detroit Receiving Hospital — Detroit

Minnesota

  • Hennepin County Hospital — Minneapolis

Nebraska

  • University of Nebraska Medical Center — Omaha

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2018-06-25
Est. Completion 2029-06-30
Phase Phase 2

Sponsor

Gaylan Rockswold

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02407028

The ClinicalTrials.gov registry entry for NCT02407028 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 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gaylan Rockswold, which has 1 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 Traumatic Brain Injury appearing as the primary indexed condition, and to 5 interventions — of which Hyperbaric oxygen (1.5 ATA, no NBH) 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: NCT02407028 reports 11 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Iowa. 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 NCT02407028 about?

NCT02407028 is a clinical study titled "Hyperbaric Oxygen Brain Injury Treatment Trial". The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial.

What is the current status of trial NCT02407028?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2018-06-25. Estimated completion is 2029-06-30.

What conditions does trial NCT02407028 study?

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

What interventions are being tested in trial NCT02407028?

The interventions under investigation include: Hyperbaric oxygen (1.5 ATA, no NBH) (DRUG), Hyperbaric oxygen (2.0 ATA, no NBH) (DRUG), Hyperbaric oxygen (2.5 ATA, no NBH) (DRUG), Hyperbaric oxygen (1.5 ATA + NBH) (DRUG), Hyperbaric oxygen (2.0 ATA + NBH) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02407028?

This trial is sponsored by Gaylan Rockswold, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02407028 being conducted?

This trial has 11 study locations across California, Florida, Iowa, Kentucky, Maryland. 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