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NCT01716182 · ClinicalTrials.gov registry record
RAMP Study: A Study Comparing Two Lumbar Fusion Procedures
A clinical trial, sponsored by Baxano Surgical.
- Terminated
- Registry status
- 200
- Enrollment target
NCT01716182: Clinical Trial study, sponsored by Baxano Surgical.
NCT01716182 is a clinical trial that was terminated before completion, run by Baxano Surgical. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01716182 was terminated before completion, sponsored by Baxano Surgical.
- TERMINATED
- Registry status
- 200 participants
- Enrollment target
Study Summary
This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.
Primary Outcome
Efficacy: Fusion of the targeted vertebral bodies (L4-L5-S1 or L5-S1) will be assessed individually at 24 months as determined by Central Radiographic Reviewer's (orthopedic surgeon) interpretation of high resolution Computed Tomography (CT) Scan.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-07 |
Why NCT01716182 stopped before completion
NCT01716182 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01716182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01716182 about?
NCT01716182 is a clinical study titled "RAMP Study: A Study Comparing Two Lumbar Fusion Procedures". This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximat...
What is the current status of trial NCT01716182?
This trial is currently terminated. The enrollment target is 200 participants. The study started on 2012-06. Estimated completion is 2014-07.
Who is sponsoring clinical trial NCT01716182?
This trial is sponsored by Baxano Surgical, which has 3 total clinical trials registered on ClinicalTrials.gov.
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