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Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2/PHASE3

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

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

NCT05969392•Gelscom SAS

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 120 years

Sex

ALL

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;
+2 more criteria

Locations (2)

Santissima Trinità Hospital Ascagliari

Cagliari, Italy

Azienda Ospedaliera Universitaria

Siena, Italy

Key Dates

Start Date

April 1, 2025

Primary Completion Date

July 1, 2025

Completion Date

April 1, 2026

Last Updated

March 11, 2025

Enrollment

ESTIMATED participants

Conditions

Pain, CervicalDiscogenic Pain

Interventions

Intradiscal Gelified Ethanol (Discogel)

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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