Clinical trial NCT00562302: Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
Official title: A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumothorax
Keywords: lung biopsy
Lead sponsor: Angiotech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Rate of Treatment Success
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of Chest Tube Placement
timeFrame: 30 days
measure: Time to Ambulation
timeFrame: 30 days
measure: Incidence of Hospital Admissions for Pneumothorax
timeFrame: 30 day
measure: Incidence of Adverse Events Related to the Procedure and Device Effects
timeFrame: 30 Day
measure: Number of Participants With Additional Chest X-rays Needed
timeFrame: 30 day
measure: Participants Discharged Beyond Hospital's Standard of Care
timeFrame: 30-day
measure: Incidence of Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging
state: Arizona
city: Tuscon
country: United States
facility: St. Josephs Radiology Limited
state: Arizona
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: San Diego
country: United States
facility: Univerisity of California, San Diego
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: New Haven
country: United States
facility: Vascular and Interventional Radiology
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Mease Health Care
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network
state: Florida
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis Medical Center
state: Missouri
city: Cincinnati
country: United States
facility: Univeristy of Cincinnati Medical Center
state: Ohio
city: Bethlehem
country: United States
facility: St Lukes Hospital
state: Pennsylvania
city: Johnstown
country: United States
facility: Memorial Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center
state: Texas
city: Kirkland
country: United States
facility: Evergreen Healthcare Diagnostic Imaging
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center & Heart Institute of Spokane
state: Washington
Study officials:
affiliation: Angiotech Pharmaceuticals
name: Rui Avelar, MD
role: STUDY_DIRECTOR
References: