NCT01850537

Prospective Study To Assess The Safety and Efficacy of the PROW LIF Procedure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: NLT Spine · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, open-label, non-randomized study. The aim of the study is to assess the safety and efficacy of the Prow LIF procedure in Transforaminal Lumbar Interbody Fusion (TLIF) procedures for the treatment of subjects with symptomatic degenerative disc disease (DDD).

Detailed description

Primary endpoints: * Safety: Incidence of device-related anticipated and unanticipated serious adverse events (SAE). However, ALL complications and adverse events (AE) will be monitored and recorded. * Primary radiographic effectiveness outcome parameter: evaluations of fusion rate.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	treatment of degenerative disc disease using the PROW LIF	TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system)

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-05-09
• Last updated: 2013-05-09

Locations

1 site across 1 country: Israel