NCT05504499 (Refine) is a NA clinical trial of Interspinous Fusion in Lumbar Spinal Stenosis, sponsored by Pacific Research Institute.

Who is sponsoring NCT05504499?

NCT05504499 is sponsored by Pacific Research Institute.

What drugs are being tested in NCT05504499?

Interventions in NCT05504499: Interspinous Fusion.

What condition does NCT05504499 study?

NCT05504499 studies Lumbar Spinal Stenosis.

Is NCT05504499 still recruiting?

NCT05504499 is currently recruiting now. Last updated 18 August 2022.

Last reviewed 2022-08-18 · How we verify

NCT05504499: Refine

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now NA Last updated 18 August 2022

What this trial tests

NA trial testing Interspinous Fusion in Lumbar Spinal Stenosis in 100 participants. Currently enrolling.

Timeline

19 March 2021

Primary endpoint
1 January 2028

1 January 2028

Quick facts

Lead sponsor	Pacific Research Institute
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	19 March 2021
Primary completion	1 January 2028
Estimated completion	1 January 2028
Sites	10 locations across United States

Drugs / interventions tested

Interspinous Fusion

Conditions studied

Lumbar Spinal Stenosis — all drugs for Lumbar Spinal Stenosis →

Sponsor

Pacific Research Institute

Who can join

18 and older, any sex, with Lumbar Spinal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.
Falowski SM, Raso LJ, Mangal V, Narizi A, et al · · 2023 · cited 2× · PMID 36264409 · DOI 10.1007/s40122-022-00447-0

Verify or expand the search:

Other recruiting trials for Lumbar Spinal Stenosis

Currently open trials in the same condition.

NCT07489001 — Opioid Free and Opioid Based Anesthesia in Elective Lumbar Spine Surgery · recruiting
NCT07233798 — Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis · recruiting
NCT07281625 — Decompressive Laminectomy Versus Laminectomy With Transpedicular Fixation in Lumbar Spinal Stenosis · EARLY_PHASE1 · recruiting
NCT07001982 — Lumbar Spinal Stenosis and Central Sensitization · recruiting
NCT06959355 — Frailty and Associated Factors in Lumbar Spinal Stenosis · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05504499 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pacific Research Institute
Last refreshed: 18 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05504499.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing