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Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy

NCT04141098 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-05-21

No results posted yet for this study

Summary

This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.

Conditions

  • Degenerative Disc Disease
  • Chronic Low-back Pain

Interventions

DEVICE

All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.

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. Any patient meeting any of the three intraoperative exclusion criteria will receive an alternative standard of care therapy.

Sponsors & Collaborators

  • Spinal Stabilization Technologies

    lead INDUSTRY

Principal Investigators

  • Michael Hess, MD · London Spine Clinic/ATOS-Klinik

  • Jeff Golan, MD · Jewish General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2023-02-01
Completion
2023-08-07

Countries

  • Paraguay

Study Locations

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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 NCT04141098 on ClinicalTrials.gov