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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Ospedale di Vimercate - ASST Brianza
RECRUITING
Vimercate
Contact Information
Primary
Aurel Mengri, MD
aurel.mengri@asst-brianza.it
+39039 6654839
Time Frame
Start Date: 2025-03-10
Estimated Completion Date: 2030-11-23
Participants
Target number of participants: 45
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Aurel Mengri

This content was sourced from clinicaltrials.gov