MedTrace Logo

RCT Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain GelStix Study

NCT02763956 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-02-22

No results posted yet for this study

Summary

Degenerative Disc Disease is one of the most common spinal pathologies, affecting up to 10-15 % of adults. The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population with discogenic pain that had no benefit from conservative care.

Conditions

  • Degeneration of Lumbar Intervertebral Disc

Interventions

DEVICE

GelStix™ Nucleus Augmentation Device

Intradiscal Gelstix insertion

OTHER

Placebo

Intradiscal saline injection

Sponsors & Collaborators

  • Rijnstate Ziekenhuis, Arnhem, The Netherlands

    collaborator UNKNOWN

  • Paolo Maino, Sponsor-Investigator

    collaborator UNKNOWN

  • Ospedale Regionale di Lugano

    lead OTHER

Principal Investigators

  • Eva Koetsier, MD PhD LLM · Centro Terapia del Dolore, EOC Lugano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Netherlands
  • Switzerland

Study Locations

More Related Trials

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 NCT02763956 on ClinicalTrials.gov