Gelified radiopaque ethanol for cervical disc herniation in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GENESIS is a single-center, non-interventional study that collects real-world data on adults treated with radiopaque gelified ethanol for cervical disc herniation. It describes clinical and radiological outcomes from routine care, with no changes to treatment or follow-up dictated by the study. Data are gathered from both past and current patients to understand the natural course after this intradiscal therapy. The study aims to describe safety and effectiveness signals in a real-world setting within approved indications. About 45 participants are planned for inclusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged 18 to 75 years, already treated with or candidate for Absolute Gel for cervical disc herniation as part of standard clinical practice
* Signed informed consent to participate in the study (prospective participants; retrospective participants according to the conditions approved by the Ethics Committee)
* Discogenic neck pain confirmed by a history of cervical neck pain, with at least 3 months of continuous pain or 6 months of acute recurrent episodes despite conservative treatment including analgesics and physiotherapy
* Baseline neck pain intensity VAS greater than 4 out of 10
* Cervical disc herniation documented by MRI
* Contained herniation without complete annulus tear, with integrity of the posterior longitudinal ligament and no free fragments, assessed by MRI or CT

Exclusion Criteria:

* Active local or systemic infection (systemic or cervical)
* Known contraindications to ethanol or to device components
* Coagulopathy or anticoagulant therapy that cannot be discontinued according to clinical practice
* Serious medical or systemic disease making the treatment inappropriate according to clinical judgement
* Psychiatric or cognitive disorders preventing a reliable assessment
* Pregnancy or breastfeeding
* Sequestered or migrated disc herniation
* Severe disc degeneration not compatible with the clinical use of Absolute Gel (for example disc collapse greater than 60%, Pfirrmann grade IV-V according to clinical judgement)
* Clinically significant severe foraminal or central stenosis
* Instability (for example spondylolisthesis greater than Meyerding grade I)
* Significant vertebral abnormalities (for example fractures, active angiomas, severe scoliosis greater than 20 degrees Cobb, significant kyphosis)
* Severe posterior osteophytes compromising access or treatment safety
* Clinically significant facet joint disorders (for example severe osteoarthritis)
* Inadequate skin coverage or local conditions impeding the procedure
* Previous cervical surgery at the treated disc level
* Severe neurological deficit (for example motor strength less than 3/5) not exclusively attributable to the contained herniation
* Any other condition that, in the judgement of the treating physician, makes the treatment inappropriate in routine clinical practice

Where it's running

• Ospedale di Vimercate - ASST Brianza
  Vimercate, Monza E Brianza, Italy Recruiting

Study contacts

• Principal investigator: Aurel Mengri, MD — ASST Brianza - Ospedale di Vimercate
• Study coordinator: Aurel Mengri, MD
• Email: aurel.mengri@asst-brianza.it
• Phone: +39039 6654839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.