M6-C Post Approval Study (PAS) (NCT04122248) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
M6-C Post Approval Study (PAS)
United States152 participantsStarted 2019-11-30
Plain-language summary
The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.
Who can participate
Age range21 Years – 68 Years
SexALL
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Inclusion Criteria:
* Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria
Exclusion Criteria:
* Subjects who were withdrawn or withdrew consent to participate in the investigation
* Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
* Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS