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NCT03927508 · ClinicalTrials.gov registry record · Phase 1

First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

A Phase 1 study of Pulmonary Embolism, sponsored by Thrombolex.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target
5
Study locations

NCT03927508 is a Phase 1 study of Pulmonary Embolism that has completed, run by Thrombolex. The registered enrollment target is 9 participants, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT03927508, a Phase 1 study of Pulmonary Embolism, has completed, sponsored by Thrombolex.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target
5
Study locations

Study Summary

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

Conditions Studied

Interventions

  • DRUG r-tPA
  • DEVICE The Bashir™ Endovascular Catheter

Study Locations (5)

Pennsylvania

  • University Pittsburg Medical Center - Hamot - Erie
  • Temple University Hospital - Philadelphia

Florida

  • Advent Health Orlando - Orlando

Indiana

  • St Vincent Hospital and Health Care Center, Inc. - Indianapolis

New York

  • Columbia University Medical Center - Presbyterian - New York - New York

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2019-03-14
Est. Completion 2020-01-23
Phase Phase 1

Sponsor

Thrombolex

2 total trials

What the Registry Record Tells You About NCT03927508

The ClinicalTrials.gov registry entry for NCT03927508 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,058-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (100% lower). The listed sponsor is Thrombolex, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Embolism appearing as the primary indexed condition, and to 2 interventions - of which r-tPA is the first listed.

NCT03927508 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Pennsylvania, Florida, Indiana.

Frequently Asked Questions

What is clinical trial NCT03927508 about?

NCT03927508 is a clinical study titled "First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism". The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

What is the current status of trial NCT03927508?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2019-03-14. Estimated completion is 2020-01-23.

What conditions does trial NCT03927508 study?

This clinical trial studies the following conditions: Pulmonary Embolism.

What interventions are being tested in trial NCT03927508?

The interventions under investigation include: r-tPA (DRUG), The Bashir™ Endovascular Catheter (DEVICE).

Who is sponsoring clinical trial NCT03927508?

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

Where is trial NCT03927508 being conducted?

This trial has 5 study locations across Florida, Indiana, New York, Pennsylvania. 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.