Adherus™ Dural Sealant in Spinal Procedures

NCT04498026 | Enrolling By Invitation FDA Device

• 1 other identifier: HBMT-US-2019-001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures. This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.

Conditions

Spinal Duraplasty

Keywords

Adherus Dural Sealant; Adherus AutoSpray Dural Sealant; Dura mater; Durotomy; CSF leak

Outcome Measures

Primary Outcomes (1)

• The proportion of treated subjects who are free from the following incidences:

  * CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 90-day follow-up period following the index procedure * Unplanned retreatment of the original surgical site adjudicated by the Clinical Events Committee (CEC) to be device-related, other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 90-day follow-up period including: * treatment for deep infection * treatment for meningitis * minimally invasive procedures or return to the operating room for neurosurgical complications

  90 Days

Secondary Outcomes (1)

• Secondary endpoints, which will only be tested for superiority of Adherus over DuraSeal Exact after the primary objective of the study has been met:

  30 Day, 90 Day

Study Arms (2)

Adherus Dural Sealant System

EXPERIMENTAL

Device: Adherus Dural Sealant, In situ polymerizing sealant

Device: Adherus Dural Sealant System

DuraSeal Exact Dural Sealant System

ACTIVE COMPARATOR

Device: DuraSeal Exact (P080013b)

Device: DuraSeal Exact Dural Sealant System

Interventions

Adherus Dural Sealant System DEVICE

Adherus Dural Sealant, In situ polymerizing sealant

Adherus Dural Sealant System

DuraSeal Exact Dural Sealant System DEVICE

DuraSeal Exact (P080013b)

DuraSeal Exact Dural Sealant System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 and ≤ 75 years old.
• 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).
• Subject is able and willing to provide informed consent and HIPAA authorization.
• Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
• Subject has durotomy edges that can be re-approximated using the investigator's standard methods of dural repair.

You may not qualify if:

• Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
• Subject has a pre-existing external lumbar CSF drain or internal CSF shunt.
• Subject has experienced previous CSF leak (secondary to trauma, neoplasm, surgery, or other etiology).
• Subject is undergoing a Chiari malformation procedure.
• Subject has undergone a previous spinal procedure in the same anatomical location.
• Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post indexprocedure.
• Subject has spinal metallic implants that may cause significant imaging artifact on the MRI evaluation of the spine.
• Subject has a known malignancy or another condition with anticipated survival shorter than six months.
• Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or chemotherapy treatment is planned within two weeks after the index procedure is performed.
• Subject has been treated with chronic steroid therapy (defined as regular (daily) administration of steroid agent(s) for ≥ 8 weeks) unless discontinued greater than four weeks prior to the planned index procedure. Note: standard acute perioperative steroids are permitted; administration of steroid agents for \< 8 weeks duration prior to the planned index procedure is permitted.
• Subject has received warfarin, heparin, other anticoagulant agents, aspirin or non steroid anti-inflammatory agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
• Subject has a compromised immune system or autoimmune disease or is on chronic immunosuppressant agents at baseline.
• Subject has a systemic infection or evidence of any infection near planned operative site.
• Subject has a serum creatinine level \> 2.0 mg/dL.
• Subject has a serum total bilirubin \> 2.5 mg/dL at baseline.

Sponsors & Collaborators

• Stryker Craniomaxillofacial: lead
• Fortrea: collaborator

Study Sites (14)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California Davis Health

Sacramento, California, 95817, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Mayo Clinic (FL)

Jacksonville, Florida, 32224, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid Leak; Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: November 19, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

US (14)