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NCT04171544 Clinical Trial

Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up

Spinal Disease Clinical Trial

— OCT PMCF  

Official title:
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04171544
Other study ID # 1108-CL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 6, 2019
Est. completion date March 31, 2020

Study information
Verified date October 2020
Source RTI Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.

Description:

This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System. The study will include a minimum of 58 patients at a minimum of 3 sites in the United States. The study will enroll at a minimum of 5 subjects implanted with the occipital plate.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Subject must have had an implant of the OCT System. Exclusion Criteria: - No exclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Streamline Occipito-Cervico-Thoracic Spinal Fixation System
Spinal Fixation

Locations
Country Name City State
United States Las Vegas Neurosurgical Institute Las Vegas Nevada
United States Spine Nevada Reno Nevada

Sponsors (1)
Lead Sponsor Collaborator
RTI Surgical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate time to demonstration of fusion. Evaluate time to demonstration of fusion. 12 months
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