ClinicalTrials.gg
CompletedNCT02425631Updated Sep 13, 2016

CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

An observational study in Sacroiliitis, sponsored by Zyga Technology, Inc.. Completed. Per ClinicalTrials.gov, last updated 2016-09-13.

Sponsored by Zyga Technology, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
19
Sex
All
01

Study summary

This study will evaluate long-term follow-up of subjects implanted with the SImmetry Sacroiliac (SI) Joint Fusion System (SImmetry).

02

Conditions studied

  • Sacroiliitis

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Keywords

  • SI joint fusion
  • SI joint pain
  • SI joint
  • SI joint treatment
  • SI joint disease
  • Sacroiliac joint
  • Simmetry
03

In context

Sacroiliitis

42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.

This study's enrollment of 19 is below the median of 120 across 13 observational studies indexed under Sacroiliitis.

Browse Sacroiliitis studies →

Lead sponsor

Zyga Technology, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients implanted with the SImmetry System will be recruited for this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient must have a SImmetry device implanted.
  • Patient is willing to comply with study procedures and provide .

Exclusion criteria

Exclusion Criteria:

  • Patient is physically unable to return to the clinic for CT imaging.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
19 participants (actual)
Patient registry
No

Interventions

  • DeviceSImmetry Sacroiliac Joint Fusion System

    Minimally invasive surgery for implantation of the SImmetry System

06

What researchers measure

Primary outcomes

  1. SI Joint Fusion (CT evidence of SI joint fusion)

    CT evidence of SI joint fusion evaluated by a core laboratory

    Time frame: 12 months

Secondary outcomes

  1. SI Joint Pain (CT evidence of SI joint fusion)

    evaluated by a core laboratory

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02425631
Lead sponsor
Zyga Technology, Inc.
Responsible party
Sponsor
First posted
Apr 24, 2015
Start date
Oct 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Sep 13, 2016

Study contacts

Lisa Ingham
study director · Zyga

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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