Treatment of Adolescent Idiopathic Scoliosis Patients Usi... | NCT01633931

Studies
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

NCT01633931

Sponsor

Ellipse Technologies, Inc.

Status

Unknown status

Last Update Posted

Feb 1, 2018Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Adolescent Idiopathic Scoliosis

Interventions

Not provided

Countries

Hong Kong

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012Actual

Primary Completion Date

Apr 2012Actual

Completion Date

Oct 2018Estimated

First Submitted Date

Jul 2, 2012

First Submission Date that Met QC Criteria

Jul 5, 2012

First Posted Date

Jul 6, 2012Estimated

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

Jan 30, 2018

Last Update Posted Date

Feb 1, 2018Actual

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in major scoliotic curve magnitude	Measured in degrees	Change from baseline to 36 months postoperative
Number and Types of Adverse Events		Operative through 36 months postoperative

Secondary Outcomes

Measure	Description	Time Frame
Radiographic evaluation coronal balance compared to baseline		Change from baseline to 36 months postoperative
Radiographic evaluation sagittal balance compared to baseline		Change from baseline to 36 months postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Adolescent Idiopathic Scoliosis
Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
Skeletally immature (Risser Sign 0, 1, 2, or 3)
In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
Age between 10 and 15
Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
Candidate for surgical implantation of spinal instrumentation
Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
Must sign informed consent to permit the use of personal health data

Exclusion Criteria:

Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
Patients who require an MRI following implantation
Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
History of previous surgical treatment for AIS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Patients diagnosed with Adolescent Idiopathic Diagnosis

Sampling Method

Non-Probability Sample