Spinal Stenosis Occipito-Atlanto-AxialOCT PMCFNCT04171544
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up
An observational study of Spinal Stenosis Occipito-Atlanto-Axial and Spinal Disease, run by RTI Surgical at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Stenosis Occipito-Atlanto-Axial, Spinal Disease, Spinal Stenosis Cervical
- What is being tested?
- Streamline Occipito-Cervico-Thoracic Spinal Fixation System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Aug 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects implanted with the OCT System.
Who may be able to join
- Subject must have had an implant of the OCT System.
Who cannot join
- No exclusion criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Las Vegas Neurosurgical Institute
Las Vegas, Nevada, 89117
Spine Nevada
Reno, Nevada, 89521
About this study
Official title: Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.
Read the detailed 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.
- Conditions
- Spinal Stenosis Occipito-Atlanto-Axial, Spinal Disease, Spinal Stenosis Cervical, Spinal Stenosis Cervicothoracic Region, Spinal Instability
- Being tested
- Streamline Occipito-Cervico-Thoracic Spinal Fixation System
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streamline Occipito-Cervico-Thoracic Spinal Fixation SystemDevice
Also called Streamline OCT
Spinal Fixation
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate time to demonstration of fusion.
Evaluate time to demonstration of fusion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start6 Aug 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis Occipito-Atlanto-AxialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171544
- Sponsor's protocol ID
- 1108-CL
- Acronym
- OCT PMCF
- Status last verified
- Oct 2020
- First submitted
- 19 Nov 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (OCT PMCF)
- ClinicalTrials.gov ID
- NCT04171544
- Acronym / sponsor ID
- OCT PMCF / 1108-CL
- Conditions
- Spinal Stenosis Occipito-Atlanto-Axial, Spinal Disease, Spinal Stenosis Cervical, Spinal Stenosis Cervicothoracic Region, Spinal Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- RTI SurgicalIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects implanted with the OCT System.
Key inclusion criteria (1 listed)
- Subject must have had an implant of the OCT System.
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Streamline Occipito-Cervico-Thoracic Spinal Fixation SystemAlso: Streamline OCTSpinal Fixation | Device | – |
Primary outcome
Evaluate time to demonstration of fusion.
Time frame: 12 months
Evaluate time to demonstration of fusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis Occipito-Atlanto-Axial and Spinal Disease, run by RTI Surgical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate time to demonstration of fusion. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.