The Clinical Study of Novosis in Posterolateral Fusion | NCT01764906

Studies
The Clinical Study of Novosis in Posterolateral Fusion

NCT01764906

Sponsor

BioAlpha Inc.

Status

Unknown status

Last Update Posted

Apr 22, 2015Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Posterolateral Fusion

Interventions

Novosis
Iliac crest bone graft

Countries

South Korea

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jan 7, 2013

First Submission Date that Met QC Criteria

Jan 8, 2013

First Posted Date

Jan 10, 2013Estimated

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

Apr 21, 2015

Last Update Posted Date

Apr 22, 2015Estimated

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

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Novosis	Experimental	Bongros/rhBMP-2	Device: Novosis
Iliac crest bone graft	Active Comparator	Iliac crest bone graft	Procedure: Iliac crest bone graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novosis	Device		Novosis
Iliac crest bone graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fusion grade by CT assessments after surgery		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fusion grade by Radiographic assessments after surgery		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18~80 aged patients needed single-level posterolateral fusion at L1~S1
A subject who provided written informed consent to participate in this study

Exclusion Criteria:

Patients with BMD T-score < -3.0
Women who are pregnant or plan to be pregnant within study period

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SMG-SNU Boramae Medical Center		Seoul			South Korea