CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System | NCT02425631

Studies
CT Follow-Up of the SImmetry Sacroiliac Joint Fusion System

NCT02425631

Sponsor

Zyga Technology, Inc.

Status

Completed

Last Update Posted

Sep 13, 2016Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Sacroiliitis

Interventions

SImmetry Sacroiliac Joint Fusion System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Apr 16, 2015

First Submission Date that Met QC Criteria

Apr 23, 2015

First Posted Date

Apr 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2016

Last Update Posted Date

Sep 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SImmetry Sacroiliac Joint Fusion System	Device	Minimally invasive surgery for implantation of the SImmetry System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SI Joint Fusion (CT evidence of SI joint fusion)	CT evidence of SI joint fusion evaluated by a core laboratory	12 months

Secondary Outcomes

Measure	Description	Time Frame
SI Joint Pain (CT evidence of SI joint fusion)	evaluated by a core laboratory	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patient is physically unable to return to the clinic for CT imaging.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Lisa Ingham	Zyga	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D058566	Sacroiliitis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided