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NCT02407028 · ClinicalTrials.gov registry record · Phase 2

Hyperbaric Oxygen Brain Injury Treatment Trial

A Phase 2 study of Traumatic Brain Injury, sponsored by Gaylan Rockswold.

Recruiting
Registry status
Phase 2
Development phase
200
Enrollment target
11
Study locations

NCT02407028 is a Phase 2 study of Traumatic Brain Injury that is actively recruiting participants, run by Gaylan Rockswold. The registered enrollment target is 200 participants, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (28% lower). The trial reports 11 study locations across 11 states.

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The verdict

NCT02407028, a Phase 2 study of Traumatic Brain Injury, is actively recruiting participants, sponsored by Gaylan Rockswold.

RECRUITING
Registry status
Phase 2
Development phase
200 participants
Enrollment target
11
Study locations

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

What the Registry Record Tells You About NCT02407028

The ClinicalTrials.gov registry entry for NCT02407028 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (28% lower). The listed sponsor is Gaylan Rockswold, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT02407028 reports 11 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Iowa.

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.

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).

Who is sponsoring clinical trial NCT02407028?

This trial is sponsored by Gaylan Rockswold, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.