A Prospective Randomized Multi-Centered Study and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures
18 Years
N/A
Both
Lung Cancer
Trial Information
A Prospective Randomized Multi-Centered Study and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures
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.
Inclusion Criteria:
1. The patient, or legal representative, must understand and provide written consent for
the procedure
2. 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 x-ray that
are suspicious by radiographic or clinical means and require biopsy.
3. The patient must meet all medical conditions for lung biopsy;
4. The patient must be at least 18 years of age;
Exclusion Criteria:
1. Patients with radiological findings of bullous emphysema, and the bullae are located
near the intended area for biopsy. (Patients may enter the study who have
radiological findings of bullous emphysema, as long as the cysts, blebs, or bullae
are not in the area of the anticipated biopsy, and biopsy needle track).
2. Female patients who are pregnant. Note: patients of childbearing potential should
have a pregnancy test no more than one week prior to the biopsy procedure, and be
instructed to have no unprotected sexual intercourse after the test until the biopsy
procedure is completed
3. Patients who are uncooperative or cannot follow instructions
4. Patients who are currently enrolled in another Investigational New Drug (IND) or
Device Exemption (IDE) clinical investigation that has not completed the required
follow-up period
5. Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory
status;
6. Patients with fungal infections (Patients with known or imaging evidence highly
suggestive of pulmonary fungal infection)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Number of Participants With Absence of Pneumothoraces
Outcome Description:
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).
Outcome Time Frame:
X-Rays at 0-60 minutes, 24 hours and 30 days
Safety Issue:
No
Principal Investigator
Sanjay Gupta, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2005-0268
NCT ID:
NCT00527722
Start Date:
September 2005
Completion Date:
December 2008
Related Keywords:
- Lung Cancer
- Lung Cancer
- Bio-Seal Track Plug
- Lung Biopsy
- Lung Plug
- Air Leaks
- Lung Neoplasms
Name | Location |
|---|---|
| U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |
