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ClinicalTrials.gov ID

NCT05969392

Lead Sponsor

Gelscom SASINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2Phase 3

Enrollment

60Estimated

Last Update Posted

Mar 11, 2025Actual

Start Date

Apr 2025Estimated

Primary Completion Date

Jul 2025Estimated

Completion Date

Apr 2026Estimated

Official Title

Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.

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 with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months

• Pain, Cervical
• Discogenic Pain

• Intradiscal Gelified Ethanol (Discogel)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Gelscom SASINDUSTRY

matteo.bellini@icloud.com