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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Intervertebral Disc Displacement; Neck Pain; Radiculopathy; Cervical Disc Herniation
• Intervention / Treatment: Device: Absolute Gel (radiopaque gelified ethanol)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Aurel Mengri, MD; Phone Number: +39039 6654839; Email: aurel.mengri@asst-brianza.it

Study Locations

• Italy
  • Monza E Brianza
    • Vimercate, Monza E Brianza, Italy, 20871
      • Recruiting
      • Ospedale di Vimercate - ASST Brianza
      • Contact: Aurel Mengri, MD; Phone Number: +390396654839
      • Principal Investigator: Aurel Mengri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: OTHER

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Absolute Gel in routine clinical practice; 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.; Other Names: Radiopaque gelified ethanol; Intradiscal chemonucleolysis with gelified ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and 1 month (+/-14 days) after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline (MRI not older than 6 months) and approximately 3 months, when performed for clinical reasons

Collaborators and Investigators

• Sponsor: Aurel Mengri
• Investigators: Principal Investigator: Aurel Mengri, MD, ASST Brianza - Ospedale di Vimercate

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): November 23, 2030

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Observational study; Real-world evidence; Cervical disc herniation; Post-market clinical follow-up; Absolute Gel; Radiopaque gelified ethanol; Intradiscal chemonucleolysis; Discogenic neck pain; Minimally invasive spine procedure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Radiculopathy; Chronic Pain; Intervertebral Disc Displacement; Neck Pain
• Other Study ID Numbers: GENESIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No