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Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3

NCT05732818 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-08

No results posted yet for this study

Summary

This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.

Conditions

  • Back Pain With Radiation
  • Radiculopathy
  • Back Pain
  • Disc Herniation
  • Herniated Nucleus Pulposus
  • Herniated Disc
  • Disc Injury
  • Disk Herniated Lumbar

Interventions

DEVICE

PerQdisc Nucleus Replacement System

Lumbar spine disc nucleus replacement system. All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.

Sponsors & Collaborators

  • Raylytic GmbH

    collaborator INDUSTRY

  • Spinal Stabilization Technologies

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2026-09-16
Completion
2027-06-16

Countries

  • Paraguay
  • Uzbekistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05732818 on ClinicalTrials.gov