NCT04498026

Adherus™ Dural Sealant in Spinal Procedures

A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Stryker Craniomaxillofacial · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, controlled, single-blind, multicenter, pivotal trial that will evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact. Subjects who are undergoing spinal surgery, consent to participate in this trial and experience a durotomy will be considered for study enrollment. Following a two-tiered inclusion/exclusion consideration, subjects will be randomized intraoperatively using a 1:1 randomization ratio. Up to 90 subjects will be randomized to treatment with either Adherus Dural Sealant or DuraSeal Exact with at least 50% of subjects undergoing procedures at lumbar or lumbosacral levels. Up to 30 investigational sites within the United States will participate in this trial. A primary composite endpoint evaluating safety and effectiveness will be measured within a 90-day required follow-up period post-procedure. Subjects will be followed at discharge or between postoperative days (POD) 1-4 from the index procedure (whichever occurs first) and at 30 days and 90 days post-index procedure.

Conditions

• Spinal Duraplasty

Interventions

Type	Name	Description
DEVICE	Adherus Dural Sealant System	Adherus Dural Sealant, In situ polymerizing sealant
DEVICE	DuraSeal Exact Dural Sealant System	DuraSeal Exact (P080013b)

Timeline

• Start date: 2020-11-19
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-08-04
• Last updated: 2025-02-24

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study