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

Primary Purpose

Pneumothorax

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bio-Seal Plug
Sponsored by
Angiotech Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumothorax focused on measuring lung biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scottsdale Medical Imaging
  • St. Josephs Radiology Limited
  • UCLA School of Medicine
  • Univerisity of California, San Diego
  • Stanford University Medical Center
  • Vascular and Interventional Radiology
  • Morton Plant Mease Health Care
  • Florida Research Network
  • UMass Memorial Medical Center
  • St. Louis Medical Center
  • Univeristy of Cincinnati Medical Center
  • St Lukes Hospital
  • Memorial Medical Center
  • Rhode Island Hospital
  • Baptist Memorial Hospital
  • University of Texas/MD Anderson Cancer Center
  • Evergreen Healthcare Diagnostic Imaging
  • Sacred Heart Medical Center & Heart Institute of Spokane

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bio-Seal Group

Control Group

Arm Description

Bio-Seal Plug Implanted

Control group with no intervention

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Incidence of Chest Tube Placement
A chest tube is the definitive initial treatment of a pneumothorax.
Time to Ambulation
Incidence of Hospital Admissions for Pneumothorax
Incidence of Adverse Events Related to the Procedure and Device Effects
Anticipated, device-related adverse events that were defined in the original protocol.
Number of Participants With Additional Chest X-rays Needed
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.
Incidence of Adverse Events
Any treatment emergent adverse events (not considered device related by the investigators).

Full Information

First Posted
November 20, 2007
Last Updated
March 26, 2013
Sponsor
Angiotech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00562302
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiotech Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
lung biopsy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bio-Seal Group
Arm Type
Experimental
Arm Description
Bio-Seal Plug Implanted
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group with no intervention
Intervention Type
Device
Intervention Name(s)
Bio-Seal Plug
Other Intervention Name(s)
Bio-Seal™ Lung Biopsy Tract System
Intervention Description
Deployment of the Bio-Seal plug in needle track
Primary Outcome Measure Information:
Title
Incidence Rate of Treatment Success
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of Chest Tube Placement
Description
A chest tube is the definitive initial treatment of a pneumothorax.
Time Frame
30 days
Title
Time to Ambulation
Time Frame
30 days
Title
Incidence of Hospital Admissions for Pneumothorax
Time Frame
30 day
Title
Incidence of Adverse Events Related to the Procedure and Device Effects
Description
Anticipated, device-related adverse events that were defined in the original protocol.
Time Frame
30 Day
Title
Number of Participants With Additional Chest X-rays Needed
Time Frame
30 day
Title
Participants Discharged Beyond Hospital's Standard of Care
Description
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.
Time Frame
30-day
Title
Incidence of Adverse Events
Description
Any treatment emergent adverse events (not considered device related by the investigators).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Avelar, MD
Organizational Affiliation
Angiotech Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Medical Imaging
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
St. Josephs Radiology Limited
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univerisity of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Vascular and Interventional Radiology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
208042
Country
United States
Facility Name
Morton Plant Mease Health Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Florida Research Network
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
St. Louis Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Univeristy of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45287
Country
United States
Facility Name
St Lukes Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Memorial Medical Center
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Evergreen Healthcare Diagnostic Imaging
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Sacred Heart Medical Center & Heart Institute of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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

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