Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, C... | NCT00689923

Studies
Vertebroplasty Using Real-Time, Fluoroscopy-Controlled, Catheter-Assisted, Low-Viscosity Cement Injection

NCT00689923

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jun 4, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Osteoporosis
Compression Fracture

Interventions

Not provided

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

ID	Type	Description	Link
200710029R

Status Module

Record Verification Date

May 2008

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

Nov 2007

Primary Completion Date

Oct 2008Estimated

Completion Date

Not provided

First Submitted Date

Jun 1, 2008

First Submission Date that Met QC Criteria

Jun 3, 2008

First Posted Date

Jun 4, 2008Estimated

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

Jun 3, 2008

Last Update Posted Date

Jun 4, 2008Estimated

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

Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.

Detailed Description

Pain relief; Comparatle

Cement Leakage; Comparacle

Irradiation dose：less

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

100Estimated

Measure	Description	Time Frame
pain relief		immediately after procedure

Measure	Description	Time Frame
cement leak		immediate after procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all painful fracture that can not be relieved by pain killer.

Exclusion Criteria:

infection and malignancy in local region

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

painful vertebral compression fracture

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D050815	Fractures, Compression

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided