SacroiliitisNCT02425631
CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System
An observational study of Sacroiliitis, run by Zyga Technology, Inc..
Trial summary
This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- SImmetry Sacroiliac Joint Fusion System
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jun 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with the SImmetry System will be recruited for this study.
Who may be able to join
- Patient must have a SImmetry device implanted.
- Patient is willing to comply with study procedures and provide informed consent.
Who cannot join
- Patient is physically unable to return to the clinic for CT imaging.
About this study
This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).
- Conditions
- Sacroiliitis
- Being tested
- SImmetry Sacroiliac Joint Fusion System
- Keywords
- SI joint fusion, SI joint pain, SI joint, SI joint treatment, SI joint disease, Sacroiliac joint, Simmetry
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SImmetry Sacroiliac Joint Fusion SystemDevice
Minimally invasive surgery for implantation of the SImmetry System
What is being measured
The primary outcome is the main question the study is designed to answer.
SI Joint Fusion (CT evidence of SI joint fusion)
CT evidence of SI joint fusion evaluated by a core laboratory
Measured: 12 months
Secondary outcomes (1)
SI Joint Pain (CT evidence of SI joint fusion)
evaluated by a core laboratory
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacroiliitisStudies 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
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zyga Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Ingham, Study director, Zyga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425631
- Sponsor's protocol ID
- CL1097
- Status last verified
- Sep 2016
- First submitted
- 16 Apr 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System
- ClinicalTrials.gov ID
- NCT02425631
- Acronym / sponsor ID
- CL1097
- Conditions
- Sacroiliitis
- Keywords
- SI joint fusion, SI joint pain, SI joint, SI joint treatment, SI joint disease, Sacroiliac joint, Simmetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Zyga Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Apr 2015 (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 study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with the SImmetry System will be recruited for this study.
Key inclusion criteria (2 listed)
- Patient must have a SImmetry device implanted.
- Patient is willing to comply with study procedures and provide informed consent.
Key exclusion criteria (1 listed)
- Patient is physically unable to return to the clinic for CT imaging.
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 |
|---|---|---|
| SImmetry Sacroiliac Joint Fusion SystemMinimally invasive surgery for implantation of the SImmetry System | Device | – |
Primary outcome
SI Joint Fusion (CT evidence of SI joint fusion)
Time frame: 12 months
CT evidence of SI joint fusion evaluated by a core laboratory
1 secondary outcome
SI Joint Pain (CT evidence of SI joint fusion)
Time frame: 24 months
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 13 Sep 2016.
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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.
Lisa Ingham study director
Zyga
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliitis, run by Zyga Technology, Inc..
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 2 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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
SI Joint Fusion (CT evidence of SI joint 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 13 Sep 2016.