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

Gelscom

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Pain, Cervical; Discogenic Pain

Treatments: Device: Intradiscal Gelified Ethanol (Discogel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05969392

CLI01068

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Intradiscal Gelified Ethanol Arm

Experimental group

Description:

Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria.

Treatment:

Device: Intradiscal Gelified Ethanol (Discogel)