Evaluation of the Bio-Seal Biopsy Track Plug
The purpose of this study is to demonstrate safety and effectiveness of the Bio-Seal Biopsy Track Plug in a clinical setting for use in lung biopsy procedures to reduce the rate of air leaks, commonly associated with the procedure. The Bio-Seal System is cleared in the U.S. with an indication for use as a lung biopsy site marker.
Device: Bio-Seal Track Plug
Other: No lung plug
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Prospective Randomized Multi-Centered Study and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures|
- Number of Participants With Absence of Pneumothoraces [ Time Frame: X-Rays at 0-60 minutes, 24 hours and 30 days ] [ Designated as safety issue: No ]Treatment Success defined as absence of pneumothoraces to measure the effects of the hydrogel plug in three follow-up radiographic assessment (x-rays post procedure by 0-60 minutes, 24 hours and 30 days).
|Study Start Date:||September 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Pleural Plug
Experimental lung plug after the lung biopsy.
Device: Bio-Seal Track Plug
The lung plug will be inserted into the left track when the biopsy needle is removed. The smaller sampling needle is removed, and the lung plug is inserted through the larger needle using a delivery tool that has a plunger to push the plug in place. The lung plug remains in the track left when the larger needle is removed.
Active Comparator: No Pleural Plug
The standard lung biopsy without placement of the plug.
Other: No lung plug
Standard lung biopsy without placement of the plug.
Air leaks are the most common problem after a lung biopsy. Air leaks can be mild to severe. Mild air leaks are monitored by chest x-ray and may go away by themselves. Air leaks can cause pain and require repeated x-rays, and in some cases the need for a tube to be inserted into the chest for drainage of the air.
If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1of 2 groups. Participants in one group will receive the experimental lung plug after the lung biopsy. Participants in the other group will just have the standard lung biopsy without placement of the plug. There is an equal chance of being assigned to either group.
All participants will have the routine lung biopsy performed by their doctor with the aid of a computerized tomography (CT) scan. During a lung biopsy, a needle is inserted into the mass in the lung using the CT for guidance. A smaller needle is then inserted through the first needle to collect a sample of the tissue.
If you are assigned to receive the lung plug, it will be inserted into the track left when the biopsy needle is removed. The smaller sampling needle is removed, and the lung plug is inserted through the larger needle using a delivery tool that has a plunger to push the plug in place. The lung plug remains in the track left when the larger needle is removed.
Regardless of which group you are assigned to, you will be receive the same follow-up treatment. The rates of air leaks after the lung biopsy will be compared between 2 groups of participants. This will provide researchers with the data to learn if the lung plug should be used for all patients receiving a lung biopsy to decrease the number of air leaks.
Your doctor will watch you carefully for air leaks. You will have a chest x-ray about 1 hour after the procedure to again check for air leaks. If a leak is detected, you will receive the normal treatment for air leaks, which includes chest x-rays on a regular basis. If the air leak grows, you may need a chest tube placed for drainage. It is possible that this may require you to stay in the hospital overnight. In the most extreme cases, additional surgery may be needed to stop the air leak. Over time, your body will absorb the plug. A final x-ray will be taken 1 month after the biopsy to be sure that an air leak has not developed.
You will be asked to be in the study for 30 days. This will include the time you spend in the hospital for the biopsy and, if you have an air leak, the entire time you spend in the hospital, if it needs to be treated. In addition, you will return to your doctor the day following the biopsy and 30 days later to have a chest x-ray to look for any late air leaks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527722
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sanjay Gupta, MD||M.D. Anderson Cancer Center|