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NCT05011656 · ClinicalTrials.gov registry record · NA

Blood Purification for the Treatment of Pathogen Associated Shock

A NA study of Septic Shock, sponsored by ExThera Medical Corporation.

Active
Registry status
NA
Development phase
15
Enrollment target
9
Study locations

NCT05011656 is a NA study of Septic Shock that is active but no longer recruiting, run by ExThera Medical Corporation. The registered enrollment target is 15 participants, below the 5,059-participant average among 24 other Septic Shock trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 7 states.

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The verdict

NCT05011656, a NA study of Septic Shock, is active but no longer recruiting, sponsored by ExThera Medical Corporation.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
15 participants
Enrollment target
9
Study locations

Study Summary

This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following: • Pathogen associated shock defined as: * The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation * Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing

Conditions Studied

Septic Shock

Interventions

  • DEVICE Seraph-100 + State of the Art Care
  • DEVICE State of the Art Care

Study Locations (9)

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • Methodist Hospital - San Antonio
  • University of Texas Health Science Center at San Antonio (UT Health San Antonio) - San Antonio

District of Columbia

  • George Washington University - Washington D.C.

Georgia

  • Southeast Georgia Health System, Inc. - Brunswick

Michigan

  • University of Michigan - Ann Arbor

Minnesota

  • Mayo Clinic - Rochester

Oregon

  • Good Samaritan Hospital - Corvallis

Pennsylvania

  • Trinity Health Mid Atlantic-SMMC - Langhorne

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-04-19
Est. Completion 2025-09-30
Phase NA

Sponsor

ExThera Medical Corporation

2 total trials

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What the Registry Record Tells You About NCT05011656

The ClinicalTrials.gov registry entry for NCT05011656 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,059-participant average among 24 other Septic Shock trials with a reported enrollment target (100% lower). The listed sponsor is ExThera Medical Corporation, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Septic Shock appearing as the primary indexed condition, and to 2 interventions - of which Seraph-100 + State of the Art Care is the first listed.

NCT05011656 reports 9 study locations spanning 7 distinct geographic areas - top geographies include Texas, District of Columbia, Georgia.

Frequently Asked Questions

What is clinical trial NCT05011656 about?

NCT05011656 is a clinical study titled "Blood Purification for the Treatment of Pathogen Associated Shock". This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the...

What is the current status of trial NCT05011656?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2024-04-19. Estimated completion is 2025-09-30.

What conditions does trial NCT05011656 study?

This clinical trial studies the following conditions: Septic Shock.

What interventions are being tested in trial NCT05011656?

The interventions under investigation include: Seraph-100 + State of the Art Care (DEVICE), State of the Art Care (DEVICE).

Who is sponsoring clinical trial NCT05011656?

This trial is sponsored by ExThera Medical Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05011656 being conducted?

This trial has 9 study locations across District of Columbia, Georgia, Michigan, Minnesota, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.