PneumothoraxPhase 3NCT00562302
Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
A Phase 3 study testing Bio-Seal Plug in people with Pneumothorax, run by Angiotech Pharmaceuticals at 18 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Bio-Seal Plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 18 sitesUnited States
- Study dates
- Apr 2005to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
St Lukes Hospital
Bethlehem, Pennsylvania, 18015
Univeristy of Cincinnati Medical Center
Cincinnati, Ohio, 45287
Morton Plant Mease Health Care
Clearwater, Florida, 33756
Florida Research Network
Gainesville, Florida, 32605
University of Texas/MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Medical Center
Johnstown, Pennsylvania, 15905
Evergreen Healthcare Diagnostic Imaging
Kirkland, Washington, 98034
UCLA School of Medicine
Los Angeles, California, 90095
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Vascular and Interventional Radiology
New Haven, Connecticut, 208042
Rhode Island Hospital
Providence, Rhode Island, 02903
Univerisity of California, San Diego
San Diego, California, 92103
Scottsdale Medical Imaging
Scottsdale, Arizona, 85258
Sacred Heart Medical Center & Heart Institute of Spokane
Spokane, Washington, 99204
St. Louis Medical Center
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
St. Josephs Radiology Limited
Tuscon, Arizona, 85711
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: 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
Read the 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.
- Conditions
- Pneumothorax
- Being tested
- Bio-Seal Plug
- Keywords
- lung biopsy
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-Seal PlugDevice
Also called Bio-Seal™ Lung Biopsy Tract System
Deployment of the Bio-Seal plug in needle track
| Study group | Role | What they receive |
|---|---|---|
| Bio-Seal Group | Experimental | Bio-Seal Plug Implanted Receives: Device: Bio-Seal Plug |
| Control Group | No intervention | Control group with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (7)
Incidence of Chest Tube Placement
A chest tube is the definitive initial treatment of a pneumothorax.
Measured: 30 days
Time to Ambulation
Measured: 30 days
Incidence of Hospital Admissions for Pneumothorax
Measured: 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.
Measured: 30 Day
Number of Participants With Additional Chest X-rays Needed
Measured: 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.
Measured: 30-day
Incidence of Adverse Events
Any treatment emergent adverse events (not considered device related by the investigators).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startApr 2005
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiotech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Avelar, MD, Study director, Angiotech Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562302
- Sponsor's protocol ID
- BS-1053
- Status last verified
- Mar 2013
- First submitted
- 20 Nov 2007
- Last updated
- 27 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy
- ClinicalTrials.gov ID
- NCT00562302
- Acronym / sponsor ID
- BS-1053
- Conditions
- Pneumothorax
- Keywords
- lung biopsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Angiotech PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Nov 2007 (estimated)
- Results
- Posted 27 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Seal Group | Experimental | Device: Bio-Seal PlugBio-Seal Plug Implanted |
| Control Group | No intervention | –Control group with no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-Seal PlugAlso: Bio-Seal™ Lung Biopsy Tract SystemDeployment of the Bio-Seal plug in needle track | Device | Bio-Seal Group |
Primary outcome
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).
7 secondary outcomes
Incidence of Chest Tube Placement
Time frame: 30 days
Time to Ambulation
Time frame: 30 days
Incidence of Hospital Admissions for Pneumothorax
Time frame: 30 day
Incidence of Adverse Events Related to the Procedure and Device Effects
Time frame: 30 Day
Number of Participants With Additional Chest X-rays Needed
Time frame: 30 day
Participants Discharged Beyond Hospital's Standard of Care
Time frame: 30-day
Incidence of Adverse Events
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Avelar, MD study director
Angiotech Pharmaceuticals
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bio-Seal Plug in people with Pneumothorax, run by Angiotech Pharmaceuticals at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of Treatment Success (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2013.