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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2013 |
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Main ID: |
NCT00562302 |
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Date of registration:
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20/11/2007 |
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Primary sponsor: |
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Public title:
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Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure
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Scientific title:
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A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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339 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00562302 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Rui Avelar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Angiotech Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pneumothorax
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Intervention(s)
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Device: Bio-Seal Plug
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Primary Outcome(s)
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Incidence Rate of Treatment Success
[Time Frame: 30 days]
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Secondary Outcome(s)
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Incidence of Adverse Events
[Time Frame: 30 days]
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Incidence of Adverse Events Related to the Procedure and Device Effects
[Time Frame: 30 Day]
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Incidence of Chest Tube Placement
[Time Frame: 30 days]
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Incidence of Hospital Admissions for Pneumothorax
[Time Frame: 30 day]
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Number of Participants With Additional Chest X-rays Needed
[Time Frame: 30 day]
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Participants Discharged Beyond Hospital's Standard of Care
[Time Frame: 30-day]
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Time to Ambulation
[Time Frame: 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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