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

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

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

Study Overview

• Status: Completed
• Conditions: Pneumothorax
• Intervention / Treatment: Device: Bio-Seal Plug

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.

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Medical Imaging
    • Tuscon, Arizona, United States, 85711
      • St. Josephs Radiology Limited
  • California
    • Los Angeles, California, United States, 90095
      • UCLA School of Medicine
    • San Diego, California, United States, 92103
      • Univerisity of California, San Diego
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 208042
      • Vascular and Interventional Radiology
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Mease Health Care
    • Gainesville, Florida, United States, 32605
      • Florida Research Network
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Umass Memorial Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • St. Louis Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45287
      • Univeristy of Cincinnati Medical Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St Lukes Hospital
    • Johnstown, Pennsylvania, United States, 15905
      • Memorial Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas/MD Anderson Cancer Center
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Healthcare Diagnostic Imaging
    • Spokane, Washington, United States, 99204
      • Sacred Heart Medical Center & Heart Institute of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bio-Seal Group; Bio-Seal Plug Implanted	Device: Bio-Seal Plug; Deployment of the Bio-Seal plug in needle track; Other Names: Bio-Seal™ Lung Biopsy Tract System
No Intervention: Control Group; Control group with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Chest Tube Placement	A chest tube is the definitive initial treatment of a pneumothorax.	30 days
Time to Ambulation		30 days
Incidence of Hospital Admissions for Pneumothorax		30 day
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
Number of Participants With Additional Chest X-rays Needed		30 day
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
Incidence of Adverse Events	Any treatment emergent adverse events (not considered device related by the investigators).	30 days

Collaborators and Investigators

• Sponsor: Angiotech Pharmaceuticals
• Investigators: Study Director: Rui Avelar, MD, Angiotech Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: November 20, 2007
• First Submitted That Met QC Criteria: November 20, 2007
• First Posted (Estimate): November 22, 2007

Study Record Updates

• Last Update Posted (Estimate): March 27, 2013
• Last Update Submitted That Met QC Criteria: March 26, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: lung biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: BS-1053