Status:
NOT_YET_RECRUITING
Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
Lead Sponsor:
Gelscom SAS
Conditions:
Pain, Cervical
Discogenic Pain
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05969392
Start Date
April 1 2025
End Date
April 1 2026
Last Update
March 11 2025
Active Locations (2)
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1
Santissima Trinità Hospital Ascagliari
Cagliari, Italy, 9121
2
Azienda Ospedaliera Universitaria
Siena, Italy, 53000