Dural Sealant

Adherus Dural Sealant System for Spinal Duraplasty

Phase 3
Waitlist Available
Research Sponsored by Stryker Craniomaxillofacial
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up30 day, 90 day
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 day, 90 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 day, 90 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of treated subjects who are free from the following incidences
Secondary outcome measures
Secondary endpoints, which will only be tested for superiority of Adherus over DuraSeal Exact after the primary objective of the study has been met

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adherus Dural Sealant SystemExperimental Treatment1 Intervention
Device: Adherus Dural Sealant, In situ polymerizing sealant
Group II: DuraSeal Exact Dural Sealant SystemActive Control1 Intervention
Device: DuraSeal Exact (P080013b)

Find a site

Who is running the clinical trial?

Laboratory Corporation of AmericaIndustry Sponsor
25 Previous Clinical Trials
9,744 Total Patients Enrolled
Stryker CraniomaxillofacialLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,810 Total Patients Enrolled

Media Library

Adherus Dural Sealant System (Dural Sealant) Clinical Trial Eligibility Overview. Trial Name: NCT04498026 — Phase 3
Spinal Duraplasty Research Study Groups: DuraSeal Exact Dural Sealant System, Adherus Dural Sealant System
Spinal Duraplasty Clinical Trial 2023: Adherus Dural Sealant System Highlights & Side Effects. Trial Name: NCT04498026 — Phase 3
Adherus Dural Sealant System (Dural Sealant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04498026 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~23 spots leftby Aug 2024