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Starting soon Phase 2/3

Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain

NCT05969392 · tracked via the Priya Life Science Italy tracker
Sponsor
Gelscom SAS
Phase
Phase 2/3
Started
2025-04
Last updated
2025-03-11

Condition(s) studied

Pain, CervicalDiscogenic Pain

Investigational drug(s) / intervention(s)

Intradiscal Gelified Ethanol (Discogel)

Intradiscal Gelified Ethanol (Discogel): Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Study summary

The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
Inclusion Criteria: * Patient 18 years or older; * Pain refractory to conservative treatments for more than 2 months, non-surgical patients * Cervicobrachialgia due to disc herniation * Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI; * Patient agreeing to participate in the study and having given written consent; * Patient enrolled in a health insurance plan. Exclusion Criteria: * Prior surgical treatment of the disc(s) studied; * Sick leave of more than 12 months secondary to painful symptoms; * Patient with Modic 1 score or more * History of cognitive-behavioral disorders that could affect the completion of self-questionnaires; * Local or systemic infection, or suspicion of infection; * Severe coagulation disorders; * Other inflammatory rheumatic disease; * Severe underlying pathology with life expectancy \<1 year; * Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0); * Known allergy to contrast material and/or local anesthetic substances; * Patients who cannot read or write Italian; * Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);

Primary outcome measure(s)

  • the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months) — 3 months
    In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").

Trial sites (2)

FacilityCityRegionStatus
Santissima Trinità Hospital Ascagliari Cagliari Italy
Azienda Ospedaliera Universitaria Siena Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05969392 on ClinicalTrials.gov ↗ ← All trials in Italy