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FLXfitTM 15 TLIF Interbody Fusion Device

NCT04208048 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2023-03-14

No results posted yet for this study

Summary

The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.

Conditions

  • Degenerative Disc Disease

Interventions

DEVICE

FLXfit 15TM device

In order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2022-03-01
Completion
2022-08-22
FDA Device
Yes

Countries

  • United States

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 NCT04208048 on ClinicalTrials.gov