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NCT05504499 · ClinicalTrials.gov registry record · NA

REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain

A NA study of Lumbar Spinal Stenosis, sponsored by Pacific Research Institute.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
10
Study locations

NCT05504499 is a NA study of Lumbar Spinal Stenosis that is actively recruiting participants, run by Pacific Research Institute. The registered enrollment target is 100 participants, below the 664-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (85% lower). The trial reports 10 study locations across 8 states.

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The verdict

NCT05504499, a NA study of Lumbar Spinal Stenosis, is actively recruiting participants, sponsored by Pacific Research Institute.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.

Conditions Studied

Lumbar Spinal Stenosis

Interventions

  • DEVICE Interspinous Fusion

Study Locations (10)

Nevada

  • Comprehensive & Interventional Pain Management - Henderson
  • Nevada Advanced Pain Specialists - Reno
  • Reno Tahoe Pain Associates - Reno

California

  • Evolve Restorative Center - Santa Rosa

Florida

  • The Raso Pain Center - Jupiter

Louisiana

  • Koga Neurosurgery - Slidell

Maryland

  • National Spine and Pain Centers - Oxon Hill

New Jersey

  • The Pain Management Center - Voorhees Township

Ohio

  • Premier Pain Treatment Institute - Loveland

Pennsylvania

  • Center for Interventional Pain and Spine - Chadds Ford

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2021-03-19
Est. Completion 2028-01-01
Phase NA

Sponsor

Pacific Research Institute

1 total trials

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What the Registry Record Tells You About NCT05504499

The ClinicalTrials.gov registry entry for NCT05504499 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 664-participant average among 18 other Lumbar Spinal Stenosis trials with a reported enrollment target (85% lower). The listed sponsor is Pacific Research Institute, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lumbar Spinal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Interspinous Fusion is the first listed.

NCT05504499 reports 10 study locations spanning 8 distinct geographic areas - top geographies include Nevada, California, Florida.

Frequently Asked Questions

What is clinical trial NCT05504499 about?

NCT05504499 is a clinical study titled "REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain". The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.

What is the current status of trial NCT05504499?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-03-19. Estimated completion is 2028-01-01.

What conditions does trial NCT05504499 study?

This clinical trial studies the following conditions: Lumbar Spinal Stenosis.

What interventions are being tested in trial NCT05504499?

The interventions under investigation include: Interspinous Fusion (DEVICE).

Who is sponsoring clinical trial NCT05504499?

This trial is sponsored by Pacific Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05504499 being conducted?

This trial has 10 study locations across California, Florida, Louisiana, Maryland, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.