The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Per… (NCT07020000) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
United States120 participantsStarted 2025-08-30
Plain-language summary
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.
The primary objectives are:
* To evaluate the safety of the EARP surgical technique and devices during LIF surgeries.
* To understand the EARP fusion system's ability to achieve fusion and improve disk space over time.
Who can participate
Age range
22 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Undergoing LIF between L2-S1
Exclusion Criteria:
* BMI \>40 kg/m2
* Pregnant or plans on becoming pregnant in the near future
* Surgery requires combination of EARP with another lumbar interbody fusion technique (PLIF, TLIF, ALIF, OLIF, LLIF) or posterolateral fusion at another level
* History of lumbar interbody pseudoarthrosis at planned operative level
* Lumbar spondylolisthesis ≥ grade 3
* Osteoporotic vertebral compression fracture treated or untreated at planned operative site
* History of lumbar spinal metastasis
* Acute lumbar spine trauma requiring immediate intervention
* Owestry Disability Index (ODI) 81-100%
* Presence of personality disorder or major psychiatric illness
* History of allergy to titanium, platinum, PEEK, aluminum, stainless steel or silicone
* Any additional factor that makes the patient an unsuitable candidate for the study in the opinion of the principal investigator
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiographic measurements prior to surgery and at follow-up visits
Timeframe: From enrollment until the end of follow-up at 12 months
2
To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries
Timeframe: From surgery until the end of follow up at 12 months