NCT06127745

Discure Technologies Feasibility Study for DDD

A Prospective Study to Assess the Safety and Performance of the Discure Technologies System for the Treatment of Early to Moderate Degenerative Disc Disease (DDD).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Discure Technologies Ltd. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and performance of the Discure System therapy in subjects with early to moderate degeneration of the disc (DDD).

Detailed description

A prospective, interventional, multi-center, single arm, open label, feasibility study. The study is designed to evaluate the safety and performance of the Discure System in the treatment of chronic low back pain (with or without radicular pain) of discogenic origin with early to moderate degeneration of the disc (DDD) in levels L1-2 to L5-S1, as confirmed by history and radiographic studies and/or discography, who failed conservative treatment of 12 weeks in duration. Subjects will be followed at 1,3-, and 6-months post procedure. The primary endpoint will be assessed at the 6-month follow-up visit. The study will enroll up to 20 subjects at up to 8 sites.

Conditions

• Degenerative Disc Disease
• Chronic Low-back Pain
• Discogenic Pain

Interventions

Type	Name	Description
DEVICE	Discure System	All subjects enrolled into the study will be implanted with the Discure System in a minimally invasive procedure.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2023-11-13
• Last updated: 2023-11-14