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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 day, 90 day
Awards & highlights
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.
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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for a spine surgery that includes opening the dura mater.
Select...
I need a procedure for a clean, uninfected wound.
Select...
My surgery involves repairing the outer layer of my brain or spinal cord.
Select...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 day, 90 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 day, 90 day
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
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)
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Who is running the clinical trial?
FortreaUNKNOWN
9 Previous Clinical Trials
2,306 Total Patients Enrolled
Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
9,771 Total Patients Enrolled
Stryker CraniomaxillofacialLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having surgery for Chiari malformation.I am scheduled for a spine surgery that includes opening the dura mater.I have had surgery on my spine in the same spot before.I need a procedure for a clean, uninfected wound.I take blood thinners or anti-inflammatory drugs daily and haven't stopped before surgery.My surgery involves repairing the outer layer of my brain or spinal cord.I have an infection in my body or near where I might have surgery.My skull's membrane defect can't be closed with stitching or grafting.I have a condition that may shorten my life to under six months.My surgeon saw a gap larger than 2 mm in my dura or between the dura and the patch material before using the sealant.I have not been on daily steroids for more than 8 weeks in the last month.I was found to meet a pre-operative exclusion criterion during surgery.My diabetes is not under control, with an HbA1c level above 7%.I've had chemotherapy (not hormone therapy) within 3 weeks before, or plan to within 2 weeks after a procedure.I have had or will have radiation therapy at the surgery area within 10 days after a procedure.I have a weak immune system or an autoimmune disease.I have a significant fluid buildup in my brain.I have had a CSF leak in the past due to injury, tumor, surgery, or another cause.I am between 18 and 75 years old.I can attend all required study visits and tests.I have had surgery to relieve pressure on my spinal cord.I had surgery for syringomyelia without a shunt placed in the subarachnoid space.
Research Study Groups:
This trial has the following groups:- Group 1: DuraSeal Exact Dural Sealant System
- Group 2: Adherus Dural Sealant System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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