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COMPLETED NA

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine

NCT03928041 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.

Interventions

  • DEVICE Device: EVOS Lumbar Interbody System (EVOS-HA)

Study Locations (2)

North Carolina

  • OrthoCarolina Research Institute — Charlotte

Pennsylvania

  • Thomas Jefferson University Hospital — Philadelphia

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2019-06-27
Est. Completion 2023-09-25
Phase NA

Sponsor

Invibio

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03928041

The ClinicalTrials.gov registry entry for NCT03928041 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Invibio, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Spondylolisthesis, Grade 1 appearing as the primary indexed condition, and to 1 intervention — of which Device: EVOS Lumbar Interbody System (EVOS-HA) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03928041 reports 2 study locations spanning 2 distinct geographic areas — top geographies include North Carolina, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03928041 about?

NCT03928041 is a clinical study titled "A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine". The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.

What is the current status of trial NCT03928041?

This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2019-06-27. Estimated completion is 2023-09-25.

What conditions does trial NCT03928041 study?

This clinical trial studies the following conditions: Spondylolisthesis, Grade 1, Degenerative Disc Disease Lumbar. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03928041?

The interventions under investigation include: Device: EVOS Lumbar Interbody System (EVOS-HA) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03928041?

This trial is sponsored by Invibio, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03928041 being conducted?

This trial has 2 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial