Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure

Pneumothorax Clinical Trial

Official title:

A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562302
• Other study ID #: BS-1053
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2007
• Last updated: March 26, 2013
• Start date: April 2005
• Est. completion date: August 2008

Study information

• Verified date: March 2013
• Source: Angiotech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures

Description:

This is a multi-centered, randomized trial in patients receiving lung biopsies. Patients will be randomized to either receive or not receive a Bio-Seal Biopsy Track Plug after a lung biopsy per standard hospital protocol. This study is designed to demonstrate safety and efficacy of the Bio-Seal Biopsy Track Plug in reducing pneumothorax rates post lung biopsy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must meet all medical conditions for lung biopsy;

• The patient must be at least 18 years of age;

• The patient, or legal representative, must understand and provide written consent for the procedure;

• The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.

Exclusion Criteria:

• Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;

• Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;

• Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.

• Patients who are uncooperative or cannot follow instructions.

• Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Device:
• Bio-Seal Plug
Deployment of the Bio-Seal plug in needle track

Locations

Country	Name	City	State
United States	St Lukes Hospital	Bethlehem	Pennsylvania
United States	Univeristy of Cincinnati Medical Center	Cincinnati	Ohio
United States	Morton Plant Mease Health Care	Clearwater	Florida
United States	Florida Research Network	Gainesville	Florida
United States	University of Texas/MD Anderson Cancer Center	Houston	Texas
United States	Memorial Medical Center	Johnstown	Pennsylvania
United States	Evergreen Healthcare Diagnostic Imaging	Kirkland	Washington
United States	UCLA School of Medicine	Los Angeles	California
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Vascular and Interventional Radiology	New Haven	Connecticut
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Univerisity of California, San Diego	San Diego	California
United States	Scottsdale Medical Imaging	Scottsdale	Arizona
United States	Sacred Heart Medical Center & Heart Institute of Spokane	Spokane	Washington
United States	St. Louis Medical Center	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	St. Josephs Radiology Limited	Tuscon	Arizona
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Angiotech Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Treatment Success	Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).	30 days	Yes
Secondary	Incidence of Chest Tube Placement	A chest tube is the definitive initial treatment of a pneumothorax.	30 days	Yes
Secondary	Time to Ambulation		30 days	No
Secondary	Incidence of Hospital Admissions for Pneumothorax		30 day	Yes
Secondary	Incidence of Adverse Events Related to the Procedure and Device Effects	Anticipated, device-related adverse events that were defined in the original protocol.	30 Day	Yes
Secondary	Number of Participants With Additional Chest X-rays Needed		30 day	No
Secondary	Participants Discharged Beyond Hospital's Standard of Care	Current standard of care for hospital discharge varies. Some institutions allow the patient to be discharged after a 3 hour wait. Others allow discharge after an x-ray indicates no pneumothorax. Since this study was randomized with control patients, the time to discharge beyond the hospital's standard of care was recorded to see if a trend for later discharge was apparent. This measure indicates the number of participants who were discharged later than their hospital's standard of care.	30-day	No
Secondary	Incidence of Adverse Events	Any treatment emergent adverse events (not considered device related by the investigators).	30 days	Yes