Pathogenesis of Primary Spontaneous Pneumothorax | NCT01135004

Studies
Pathogenesis of Primary Spontaneous Pneumothorax

NCT01135004

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2010Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Pneumothorax

Interventions

Thoracoscopic bullectomy

Countries

Taiwan

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

Mar 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Feb 2012Estimated

Completion Date

Feb 2013Estimated

First Submitted Date

May 30, 2010

First Submission Date that Met QC Criteria

Jun 1, 2010

First Posted Date

Jun 2, 2010Estimated

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 1, 2010

Last Update Posted Date

Jun 2, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Name	Class
National Taiwan University Hospital, Yun-Lin Branch	OTHER
National Science and Technology Council, Taiwan	OTHER_GOV

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

Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients.

Detailed Description

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

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pneumothorax patients		Primary spontaneous pneumothorax patients undergoing thoracoscopic bullectomy	Procedure: Thoracoscopic bullectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracoscopic bullectomy	Procedure	Thoracoscopic wedge resection of the diseased lung	Pneumothorax patients

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 14 and 40 years
Spontaneous pneumothorax
Underwent bullectomy of the lung

Exclusion Criteria:

With underlying lung disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males without underlying pulmonary disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin-Shing Chen, MD, PhD	Contact	886-2-23123456	65178	chenjs@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Yung-Chie Lee, MD, PhD	National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei	Taiwan	100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16376095	Background	Ayed AK, Chandrasekaran C, Sukumar M. Video-assisted thoracoscopic surgery for primary spontaneous pneumothorax: clinicopathological correlation. Eur J Cardiothorac Surg. 2006 Feb;29(2):221-5. doi: 10.1016/j.ejcts.2005.11.005. Epub 2005 Dec 20.

ID	Term
D011030	Pneumothorax
D001768	Blister

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases
D012872	Skin Diseases, Vesiculobullous
D012871	Skin Diseases

ID	Term
D013906	Thoracoscopy
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures