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Adherus™ Dural Sealant in Spinal Procedures

NCT04498026 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-02-24

No results posted yet for this study

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

Interventions

DEVICE

Adherus Dural Sealant System

Adherus Dural Sealant, In situ polymerizing sealant

DEVICE

DuraSeal Exact Dural Sealant System

DuraSeal Exact (P080013b)

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • Stryker Craniomaxillofacial

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498026 on ClinicalTrials.gov