Topics

M6-C Post Approval Study (PAS)

2019-10-16 10:39:35 | BioPortfolio

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.

Description

A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.

Study Design

Conditions

Long Term Follow-up

Intervention

standard radiographic imaging

Location

Spinal Kinetics, LLC
Sunnyvale
California
United States
94085

Status

Enrolling by invitation

Source

Spinal Kinetics

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:35-0400

Clinical Trials [4628 Associated Clinical Trials listed on BioPortfolio]

Assessing Imaging as a Tool in Monitoring and Predicting the Progression of Parkinson Disease

The purpose of this study is to investigate the utility of dopamine transporter imaging in monitoring and predicting the progression of Parkinson disease. This study will be performed in ...

Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis

Ankylosing spondylitis (AS) is a chronic inflammatory disease that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Current therapy for AS is mainly NSAIDs a...

PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0

Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal tr...

HeartMate 3 CE Mark Study Long Term Follow-up

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue...

PubMed Articles [23189 Associated PubMed Articles listed on BioPortfolio]

Effects of sirolimus in lymphangioleiomyomatosis patients on lung cysts and pulmonary function: long-term follow-up observational study.

To determine whether sirolimus has beneficial effects on lymphangioleiomyomatosis (LAM) lung cysts in CT with long-term follow-up (FU) and to investigate whether CT is an appropriate imaging biomarker...

Long-Term Effectiveness of Cognitive Behavioral Therapy in Routine Outpatient Care: A 5- to 20-Year Follow-Up Study.

Long-term follow-ups several years after receiving cognitive behavioral therapy (CBT) are scarce and most of the existing literature describes follow-up data of randomized-controlled trials. Thus, ver...

Long-term Results of Arthroscopic Rotator Cuff Repair: Initial Tear Size Matters: A Prospective Study on Clinical and Radiological Results at a Minimum Follow-up of 10 Years.

Arthroscopic techniques are now considered the gold standard for treatment of most rotator cuff (RC) tears; however, no consensus exists on the maintenance of results over time, and long-term follow-u...

Growth and Late Detection of Post-Operative Cholesteatoma on Long Term Follow-Up With Diffusion Weighted Magnetic Resonance Imaging (DWI MRI): A Retrospective Analysis From a Single UK Centre.

To evaluate the growth rate and late detection of residual cholesteatoma on long-term follow-up with diffusion weighted magnetic resonance imaging (DWI MRI) in clinically stable ears following definit...

Growth and Late Detection of Post-Operative Cholesteatoma on Long Term Follow-Up With Diffusion Weighted Magnetic Resonance Imaging (DWI MRI): A Retrospective Analysis From a Single UK Centre.

To evaluate the growth rate and late detection of residual cholesteatoma on long-term follow-up with diffusion weighted magnetic resonance imaging (DWI MRI) in clinically stable ears following definit...

Medical and Biotech [MESH] Definitions

Three-dimensional computed tomographic imaging with the added dimension of time, to follow motion during imaging.

Health insurance to provide full or partial coverage for long-term home care services or for long-term nursing care provided in a residential facility such as a nursing home.

The use of molecularly targeted imaging probes to localize and/or monitor biochemical and cellular processes via various imaging modalities that include RADIONUCLIDE IMAGING; ULTRASONOGRAPHY; MAGNETIC RESONANCE IMAGING; fluorescence imaging; and MICROSCOPY.

Persons who have experienced prolonged survival of HIV infection. This includes the full spectrum of untreated, HIV-infected long-term asymptomatics to those with AIDS who have survived due to successful treatment.

A persistent increase in synaptic efficacy, usually induced by appropriate activation of the same synapses. The phenomenological properties of long-term potentiation suggest that it may be a cellular mechanism of learning and memory.

More From BioPortfolio on "M6-C Post Approval Study (PAS)"

Quick Search

Relevant Topic

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...


Searches Linking to this Trial