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

March 26, 2013 updated by: Angiotech Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
339

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence Rate of Treatment Success
Time Frame: 30 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Chest Tube Placement
Time Frame: 30 days
A chest tube is the definitive initial treatment of a pneumothorax.
30 days
Time to Ambulation
Time Frame: 30 days
30 days
Incidence of Hospital Admissions for Pneumothorax
Time Frame: 30 day
30 day
Incidence of Adverse Events Related to the Procedure and Device Effects
Time Frame: 30 Day
Anticipated, device-related adverse events that were defined in the original protocol.
30 Day
Number of Participants With Additional Chest X-rays Needed
Time Frame: 30 day
30 day
Participants Discharged Beyond Hospital's Standard of Care
Time Frame: 30-day
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
Time Frame: 30 days
Any treatment emergent adverse events (not considered device related by the investigators).
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angiotech Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rui Avelar, MD, Angiotech Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BS-1053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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