NCT04171544

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

November 19, 2019

Last Update Submit

October 23, 2020

Conditions

Spinal Stenosis Occipito-Atlanto-AxialSpinal DiseaseSpinal Stenosis CervicalSpinal Stenosis Cervicothoracic RegionSpinal Instability

Outcome Measures

Primary Outcomes (1)

  • Evaluate time to demonstration of fusion.

    Evaluate time to demonstration of fusion.

    12 months

Interventions

Streamline Occipito-Cervico-Thoracic Spinal Fixation SystemDEVICE

Spinal Fixation

Also known as: Streamline OCT

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects implanted with the OCT System.

You may qualify if:

  • Subject must have had an implant of the OCT System.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Las Vegas Neurosurgical Institute

Las Vegas, Nevada, 89117, United States

Location

Spine Nevada

Reno, Nevada, 89521, United States

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

August 6, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)