NCT05969392

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.

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Gelscom SAS · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pain, Cervical
• Discogenic Pain

Interventions

Type	Name	Description
DEVICE	Intradiscal Gelified Ethanol (Discogel)	Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-07-01
• Completion: 2026-04-01
• First posted: 2023-08-01
• Last updated: 2025-03-11

Locations

2 sites across 1 country: Italy