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Confirmatory Clinical Study of Oxiplex

NCT03433391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-06-27

No results posted yet for this study

Summary

This is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded clinical study to assess the safety and effectiveness for the reduction of pain and symptoms following lumbar surgery.

Conditions

  • Herniated Lumbar Disk

Interventions

DEVICE

Oxiplex

Oxiplex is a clear, viscoelastic gel that is applied to operative site during lumbar spine surgery in order to coat the nerve root with a protective barrier.

OTHER

Surgery Only

Single level partial discectomy as per standard of care procedures.

Sponsors & Collaborators

  • FzioMed

    lead INDUSTRY

Principal Investigators

  • Jeffrey Fischgrund, MD · Beaumont Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2020-06-23
Completion
2024-03-27
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 NCT03433391 on ClinicalTrials.gov