An observational study in Cervical Disc Herniation, Intervertebral Disc Displacement and Neck Pain, sponsored by Aurel Mengri. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Aurel Mengri · Observational
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.
Cervical disc herniation with chronic discogenic neck pain is commonly managed with conservative treatment, which may show limited long-term effectiveness, or with surgery, which carries higher risks and longer recovery times. Intradiscal chemonucleolysis with radiopaque gelified ethanol is a minimally invasive option already used in routine clinical practice with a CE-marked device (Absolute Gel, Class III). Published clinical evidence remains limited, particularly with long-term follow-up.
474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 117 observational studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →This is the only study on the registry with Aurel Mengri as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 to 75 years with MRI-confirmed cervical disc herniation and persistent discogenic neck pain not adequately controlled by conservative therapy, who have already been treated with, or are candidates for, intradiscal radiopaque gelified ethanol (Absolute Gel) as part of routine clinical practice at Ospedale di Vimercate, ASST Brianza. Participants are identified from the patient population of the investigator at the specialised pain management and interventional spine service. Both retrospectively and prospectively enrolled participants are included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with cervical disc herniation and chronic discogenic neck pain who receive, or have already received, intradiscal radiopaque gelified ethanol (Absolute Gel) as part of routine clinical practice, based exclusively on the decision of the treating physician. The single cohort includes both retrospectively and prospectively enrolled participants. No treatment is assigned by the study.
Device: Absolute 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.
Also known as: Radiopaque gelified ethanol, Intradiscal chemonucleolysis with gelified ethanol
Proportion of participants with a reduction of at least 30% in neck pain intensity (VAS) at 1 month
Neck pain intensity is measured with the Visual Analogue Scale (VAS), a 0 to 10 scale where 0 = no pain and 10 = worst imaginable pain. Lower scores indicate less pain. The measure is the proportion of participants whose VAS score at 1 month is reduced by at least 30% compared with baseline, reported with exact 95% binomial confidence intervals. Descriptive only; no hypothesis testing is performed.
Time frame: Baseline and 1 month (+/-14 days) after treatment
Change from baseline in neck pain intensity (VAS) at 1 month
Continuous change from baseline in VAS score (0 to 10; lower scores indicate less pain), summarised with mean, standard deviation, median, interquartile range and range. Descriptive only.
Time frame: Baseline and 1 month (+/-14 days) after treatment
Change from baseline in neck pain intensity (VAS) over time
VAS scores (0 to 10; lower scores indicate less pain) and changes from baseline at each scheduled follow-up, summarised descriptively.
Time frame: Baseline, 3, 12, 24, 36 and 48 months
Proportion of participants with a reduction of at least 50% in neck pain intensity (VAS)
Proportion of participants achieving a reduction of at least 50% in VAS score compared with baseline, reported descriptively as an indicator of a more pronounced clinical response.
Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months
Patient Global Impression of Change (PGIC)
Self-reported perception of overall change assessed with the PGIC scale (7 categories, from "very much improved" to "very much worse"; lower scores indicate greater perceived improvement). Reported as frequency distributions; the proportion of participants reporting "much improved" or "very much improved" may be reported with 95% confidence intervals, for descriptive purposes only.
Time frame: 1, 3, 12, 24, 36 and 48 months
Change from baseline in cervical function measured with the Copenhagen Neck Functional Disability Scale (CNFDS)
CNFDS is a validated 15-item questionnaire assessing neck-related functional disability, with a total score from 0 to 30; higher scores indicate greater disability. Changes from baseline are summarised descriptively.
Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months
Change from baseline in cervical function measured with the Neck Pain and Disability Scale (NPAD)
NPAD is a validated 20-item questionnaire assessing neck pain and related disability, with a total score from 0 to 100; higher scores indicate greater pain and disability. Changes from baseline are summarised descriptively.
Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months
Use of analgesic and anti-inflammatory medication compared with baseline
Qualitative and quantitative documentation of analgesic, NSAID and corticosteroid use (type, dose, duration, indication) recorded during routine follow-up and compared with pre-treatment use. Descriptive only.
Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months
Number of participants with adverse events, serious adverse events and serious adverse device effects
Incidence, type, severity, outcome and relatedness (device, procedure, other) of adverse events (AE), serious adverse events (SAE) and serious adverse device effects (SADE), collected within predefined windows: 0-24 hours, day 1-30, day 31-90, day 91-365 and beyond 365 days up to 48 months.
Time frame: From the procedure up to 48 months
Number of participants with adverse events of special interest (AESI)
Predefined AESIs: discitis/osteomyelitis; procedure-related meningitis; worsening radiculopathy with new or progressive neurological deficit.
Time frame: From the procedure up to 48 months
Number of participants undergoing surgical re-intervention at the treated level
Surgical re-intervention at the treated disc level, recorded as a clinically relevant marker of treatment failure or complication.
Time frame: 30, 90 and 365 days after the procedure
Number of device deficiencies or device malfunctions reported
Device deficiencies and malfunctions documented and reported in accordance with ISO 14155 and Regulation (EU) 2017/745.
Time frame: From the procedure up to 48 months
Radiological findings on cervical MRI performed as part of routine care
Descriptive reporting of morphological disc findings (treated level, herniation morphology, Pfirrmann grade, nerve root compression, other structural findings). No imaging is mandated by the study; MRI data are collected only if performed as part of routine clinical care.
Time frame: Baseline (MRI not older than 6 months) and approximately 3 months, when performed for clinical reasons
Plan to share: Undecided — A decision on the sharing of de-identified individual participant data has not yet been taken. Any sharing would take place only in pseudonymised or anonymised form, in accordance with Regulation (EU) 2016/679 (GDPR), Italian data protection legislation, the conditions of the informed consent and the authorisation of the competent Ethics Committee and of the institutional Data Protection Officer.
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Nov 2026, 20 months after the start.
Of 45 non-industry observational studies under Intervertebral Disc Displacement, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 69. This study's planned 20 months is below that.
Counting every sponsor, half of 49 studies reached it within 35 months; a quarter within 13 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
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Intervertebral Disc Displacement →