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

Last updated: March 7, 2025
Sponsor: Gelscom SAS
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Neck Pain

Chronic Pain

Treatment

Intradiscal Gelified Ethanol (Discogel)

Intradiscal Gelified Ethanol

Clinical Study ID

NCT05969392
CLI01068
  • Ages 18-120
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patient 18 years or older;

  • Pain refractory to conservative treatments for more than 2 months, non-surgicalpatients

  • 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

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 ofself-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 tobecome 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);

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Intradiscal Gelified Ethanol (Discogel)
Phase: 2/3
Study Start date:
April 01, 2025
Estimated Completion Date:
April 30, 2026

Study Description

After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months

Connect with a study center

  • Santissima Trinità Hospital Ascagliari

    Cagliari, 9121
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria

    Siena, 53000
    Italy

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.