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NCT01605019 · ClinicalTrials.gov registry record · NA

The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery

A NA study, sponsored by The Methodist Hospital Research Institute.

Terminated
Registry status
NA
Development phase
4
Enrollment target

NCT01605019 is a NA study that was terminated before completion, run by The Methodist Hospital Research Institute. The registered enrollment target is 4 participants.

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The verdict

NCT01605019, a NA study, was terminated before completion, sponsored by The Methodist Hospital Research Institute.

TERMINATED
Registry status
NA
Development phase
4 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery. This study is evaluating CoSeal™ when it is applied to various areas of the heart during the surgery to implant a Left Ventricular Assist Device (LVAD). the investigators are looking for evidence which indicates that CoSeal™ may be useful in reducing or stopping bleeding, the occurrence of micro emboli (small particles of air or blood), and the formation of cardiac adhesions (scar tissue strands that may form around the heart in the area of a previous LVAD operation) in patients who undergo LVAD implantation surgery.

Interventions

  • DEVICE CoSeal
  • DEVICE BioGlue® Surgical Adhesive

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2012-06
Est. Completion 2014-03
Phase NA

What the Registry Record Tells You About NCT01605019

The ClinicalTrials.gov registry entry for NCT01605019 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which CoSeal is the first listed.

NCT01605019 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01605019 about?

NCT01605019 is a clinical study titled "The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery". The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery. This study is evaluating CoSeal™ when it is applied to various areas of the heart...

What is the current status of trial NCT01605019?

This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2012-06. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01605019?

The interventions under investigation include: CoSeal (DEVICE), BioGlue® Surgical Adhesive (DEVICE).

Who is sponsoring clinical trial NCT01605019?

This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.

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.