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Dural Sealant

Adherus Dural Sealant for Spinal Duraplasty

N/A
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
Subject is scheduled for an elective spinal procedure that will require a planned durotomy.
Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation is encountered).
Must not have
Subject is undergoing a Chiari malformation procedure.
Subject has undergone a previous spinal procedure in the same anatomical location.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 day, 90 day
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults aged 18 to 75 who need elective spinal surgery involving a clean, uninfected wound. Candidates must have re-approximable durotomy edges and be able to attend follow-up visits. Exclusions include altered CSF dynamics, previous leaks or surgeries in the same spot, non-MRI compatible implants, severe health conditions like cancer with less than six months survival expectancy, recent chemotherapy or chronic steroid use without proper wash-out period, certain medication usage without pre-surgical pause, compromised immune systems or infections near the surgical site.
What is being tested?
The study tests Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant against FDA-approved DuraSeal Exact Spinal Sealant in spinal surgeries. The goal is to compare their effectiveness when used during procedures that require sealing of the dura mater (the tough outer membrane covering the brain and spinal cord) after it has been cut open.
What are the potential side effects?
Potential side effects may include allergic reactions to sealant components such as FD&C Blue #1 and Yellow #5 dyes. Other risks could involve complications from improper sealing leading to cerebrospinal fluid leaks or issues related to MRI compatibility with existing implants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a spine surgery that includes opening the dura mater.
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I need a procedure for a clean, uninfected wound.
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My surgery involves repairing the outer layer of my brain or spinal cord.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having surgery for Chiari malformation.
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I have had surgery on my spine in the same spot before.
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I take blood thinners or anti-inflammatory drugs daily and haven't stopped before surgery.
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I have an infection in my body or near where I might have surgery.
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My skull's membrane defect can't be closed with stitching or grafting.
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I have a condition that may shorten my life to under six months.
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My surgeon saw a gap larger than 2 mm in my dura or between the dura and the patch material before using the sealant.
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My diabetes is not under control, with an HbA1c level above 7%.
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I've had chemotherapy (not hormone therapy) within 3 weeks before, or plan to within 2 weeks after a procedure.
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I have had or will have radiation therapy at the surgery area within 10 days after a procedure.
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I have a weak immune system or an autoimmune disease.
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I have a significant fluid buildup in my brain.
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I have had a CSF leak in the past due to injury, tumor, surgery, or another cause.
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I have had surgery to relieve pressure on my spinal cord.
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I had surgery for syringomyelia without a shunt placed in the subarachnoid space.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of treated subjects who are free from the following incidences
Secondary study objectives
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.

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 Location

Who is running the clinical trial?

FortreaUNKNOWN
17 Previous Clinical Trials
5,137 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
31 Previous Clinical Trials
18,589 Total Patients Enrolled
Stryker CraniomaxillofacialLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Adherus Dural Sealant System (Dural Sealant) Clinical Trial Eligibility Overview. Trial Name: NCT04498026 — N/A
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 — N/A
Adherus Dural Sealant System (Dural Sealant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04498026 — N/A
~23 spots leftby Dec 2025
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