DDDOptiLIF™NCT01796535
The PerX360º System™ Registry
An observational study of DDD, run by Interventional Spine, Inc. at 2 sites in United States.
Trial summary
This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DDD
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to Jun 2013
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects treated with the Optiport™ and Opticage™ products
Who may be able to join
- Patient understands the nature of the procedure and provides written informed consent
- Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
- Age > 18 years
- Patient is treated with the Optiport™ and Opticage™ products
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Los Angeles Brain and Spine Institute
Los Angeles, California, 90036
Nancy Rappard, 323-857-5300 ext. 202, rappardnancy@gmail.com
Dr. Rappard
- Recruiting
Flagler Hospital
Saint Augustine, Florida, 32086
David Greenwald, MD
About this study
Official title: An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™
This is a multi-center, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.
Read the detailed description
For all patients participating in the registry, the following outcomes will be analyzed:
- Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain
- Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain
- Change in Oswestry Disability Index (ODI) score from baseline
- Proportion of patients with a device related complication
- Proportion of patients with lack of revision, removal, or reoperation
- Proportion of patients with radiographic fusion
- Conditions
- DDD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PerX360º System™ | Patients treated with PerX360º System™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Image Assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DDDStudies 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
- Case only
- Enrolment
- 125 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Interventional Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796535
- Sponsor's protocol ID
- TP201
- Acronym
- OptiLIF™
- Status last verified
- Mar 2013
- First submitted
- 10 Dec 2012
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multi Center, Non-Randomized (Single Arm) Registration of the PerX360º System™
- ClinicalTrials.gov ID
- NCT01796535
- Acronym / sponsor ID
- OptiLIF™ / TP201
- Conditions
- DDD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Interventional Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 21 Feb 2013 (estimated)
- 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, non-randomized post marketing surveillance registry including up to 125 patients treated with the PerX360º System™. Patients will receive a follow-up evaluation at the per physician defined time points: at discharge, an Interim 1 visit (1 month), an Interim 2 visit (3-6 months) and a Final visit (12 months). Imaging obtained at visits should be per standard of care.
Detailed description
For all patients participating in the registry, the following outcomes will be analyzed:
- Change in pain score on the Visual Analog Scale(VAS) from baseline for leg pain
- Change in pain score on the Visual Analog Scale(VAS) from baseline for back pain
- Change in Oswestry Disability Index (ODI) score from baseline
- Proportion of patients with a device related complication
- Proportion of patients with lack of revision, removal, or reoperation
- Proportion of patients with radiographic fusion
Study design
- Observational model
- Case only
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PerX360º System™ | – | –Patients treated with PerX360º System™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects treated with the Optiport™ and Opticage™ products
Key inclusion criteria (4 listed)
- Patient understands the nature of the procedure and provides written informed consent
- Patient is willing to return to the treating physician for his/her routine follow-up visits up to 12 months post treatment
- Age > 18 years
- Patient is treated with the Optiport™ and Opticage™ products
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fusion
Time frame: 1 year
Image Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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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.
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 DDD, run by Interventional Spine, Inc. 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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 15 Mar 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Butler (858 220 6904, mbutler@i-spineinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (time frame: 1 year). 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 15 Mar 2013.