Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis (NCT05961956) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
Luxembourg5 participantsStarted 2023-10-12
Plain-language summary
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
Who can participate
Age range
18 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
. Male or female patients aged ≥18 years to ≤80 years.
. Patient diagnosed with symptomatic DLS with confirmed:
. Classification: Meyerding grade I or II DLS
. One vertebral segment within the lumbar region from L1-S1
. Availability of AP and LAT X-ray, MRI and/or CT scan at which the diagnosis was made.
. The estimated volume of targeted disc space to be filled (both inside and around the interbody cage) should not exceed 10cc.
. Clinically meaningful pain or neurological symptoms with or without claudication confirmed by a preoperative ODI score \>30, which have been unresponsive to a minimum of 3 consecutive months of structured conservative medical management (including at least pain medication, activity modification, and daily exercise).
. Patient is eligible for surgery by minimally invasive or open transforaminal lumbar interbody fusion (TLIF)3.
Exclusion criteria
. History of previously attempted spinal fusion at the same vertebral level, or at a level immediately adjacent to the level intended to undergo the spondylodesis. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
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.