NCT06860867

PerQdisc Traditional Feasibility Trial.

A Multi-center Traditional Feasibility Trial of the PerQdisc Artificial Implant in Treatment of Single-level Discogenic Back Pain.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Spinal Stabilization Technologies · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label. After a screening period, qualified participants will be enrolled and treated with the PerQdisc. Patients will not be blinded to their treatment. Participants will then complete the safety follow-up period.

Detailed description

The proposed investigation is a multicenter, prospective, traditional feasibility study of the PerQdisc. A minimum of N=5 subjects will be enrolled. Subjects will be enrolled in approximately 2 sites. Data analyses including all enrolled subjects meeting specific criteria will be submitted to the FDA to support a pivotal trial and used in trial planning. This study will evaluate the safety and effectiveness of the PerQdisc device in the treatment of single level discogenic back pain caused by degenerative disc disease (DDD) (L1 to L5).

Conditions

• Discogenic Low Back Pain

Interventions

Type	Name	Description
DEVICE	PerQdisc	PerQdisc Artificial Implant

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-09-30
• Completion: 2030-03-31
• First posted: 2025-03-06
• Last updated: 2026-03-24

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study