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NCT04086550 · ClinicalTrials.gov registry record · NA

Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

A NA study, sponsored by Polyganics.

Completed
Registry status
NA
Development phase
228
Enrollment target

NCT04086550 is a NA study that has completed, run by Polyganics. The registered enrollment target is 228 participants.

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The verdict

NCT04086550, a NA study, has completed, sponsored by Polyganics.

COMPLETED
Registry status
NA
Development phase
228 participants
Enrollment target

Study Summary

The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.

Interventions

  • DEVICE LIQOSEAL
  • DEVICE DuraSeal, Adherus

Trial Details

FieldValue
Enrollment Target 228 participants
Start Date 2021-05-20
Est. Completion 2024-02-13
Phase NA

Sponsor

Polyganics

2 total trials

What the Registry Record Tells You About NCT04086550

The ClinicalTrials.gov registry entry for NCT04086550 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Polyganics, which has 2 total studies on file at ClinicalTrials.gov.

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

NCT04086550 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04086550 about?

NCT04086550 is a clinical study titled "Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery". The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control grou...

What is the current status of trial NCT04086550?

This trial is currently completed. It is a NA study. The enrollment target is 228 participants. The study started on 2021-05-20. Estimated completion is 2024-02-13.

What interventions are being tested in trial NCT04086550?

The interventions under investigation include: LIQOSEAL (DEVICE), DuraSeal, Adherus (DEVICE).

Who is sponsoring clinical trial NCT04086550?

This trial is sponsored by Polyganics, which has 2 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.