RecruitingNCT07832929

Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)

Gelified Radiopaque Ethanol (Absolute Gel) for Cervical Disc Herniation: an Observational Study in Routine Clinical Practice - GENESIS Study

Sponsor

Aurel Mengri

Enrollment

45 participants

Start Date

Mar 10, 2025

Study Type

OBSERVATIONAL

Conditions

intervertebral disc displacement Chronic Pain Cervical Disc Herniation Neck Pain radiculopathy

Summary

GENESIS is a single-centre, observational, non-interventional, no-profit, investigator-initiated study conducted at Ospedale di Vimercate, ASST Brianza (Italy). The study describes the clinical and functional course of adult patients with cervical disc herniation and chronic discogenic neck pain who receive intradiscal radiopaque gelified ethanol (Absolute Gel), a CE-marked Class III medical device, as part of routine clinical practice and within its approved indications. The study does not assign, introduce or modify any treatment, procedure, medication or follow-up schedule. The decision to treat is taken exclusively by the treating physician according to standard clinical practice. The study only collects clinical and radiological data generated during routine care, both retrospectively (patients already treated) and prospectively (patients treated independently of study participation). Approximately 45 participants are planned. The main descriptive measure is the proportion of participants achieving a reduction of at least 30% in neck pain intensity (Visual Analogue Scale, VAS) at 1 month compared with baseline. Participants are followed up to 48 months after treatment. All analyses are descriptive. The study is not designed to demonstrate efficacy, to support causal inference, or to perform comparisons with other treatments.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria17

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

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Interventions

DEVICEAbsolute Gel (radiopaque gelified ethanol)

CE-marked Class III medical device used within its approved indications as part of standard clinical care. Intradiscal injection of radiopaque gelified ethanol at the cervical level, performed under fluoroscopic guidance through an antero-lateral approach with local anaesthesia, typically 0.3 to 0.4 mL per disc. The study does not assign, impose or modify the treatment, the technique or the peri-procedural management; it records the procedure as performed in routine practice.