Adherus Dural Sealant System for Spinal Duraplasty
Study Summary
This trial is testing an experimental device called the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant in spinal surgical procedures, to see if it is as effective as the DuraSeal Exact Spinal Sealant, which is already FDA approved.
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Study Objectives
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Trial Design
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Frequently Asked Questions
Does this research opportunity extend to younger people?
"The age requirements to participate in this trial are that individuals must be over 18 but under 75 years old."
Is this trial readily available in different states?
"There are a total of 14 participating clinical trial sites for this research. They are located in Saint Alphonsus (Boise, ID), University of Illinois at Chicago (Chicago, IL), Rush University Medical Center (Duarte, CA), and 11 additional sites."
Are there specific demographics that are more likely to be helped by this research?
"In order to qualify for this clinical study, potential participants must meet the age and surgery requirements. The study, which is currently looking for around 256 individuals, is only open to those who have had spinal duraplasty and are aged between 18 and 75."
Are there any opportunities for new patients to join this clinical trial?
"The trial is closed to recruitment, as reflected on clinicaltrials.gov. This study was first made public on November 19th, 2020 and was last updated on October 8th, 2020. There is one other active clinical trial at this time."
Does the Adherus Dural Sealant System have FDA approval?
"There is both prior clinical data supporting the Adherus Dural Sealant System's efficacy and multiple rounds of data affirming its safety, so it received a score of 3."