Evaluation of the Bio-Seal Biopsy Track Plug

NCT00527722 | Completed Phase 2 Results DMC

• 1 other identifier: 2005-0268
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Bio-Seal Track Plug; Lung Biopsy; Lung Plug; Air Leaks

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Absence of Pneumothoraces

  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).

  X-Rays at 0-60 minutes, 24 hours and 30 days

Study Arms (2)

Pleural Plug

EXPERIMENTAL

Experimental lung plug after the lung biopsy.

Device: Bio-Seal Track Plug

No Pleural Plug

ACTIVE COMPARATOR

The standard lung biopsy without placement of the plug.

Other: No lung plug

Interventions

Bio-Seal Track Plug DEVICE

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.

Pleural Plug

No lung plug OTHER

Standard lung biopsy without placement of the plug.

No Pleural Plug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 x-ray that are suspicious by radiographic or clinical means and require biopsy.
• The patient must meet all medical conditions for lung biopsy;
• The patient must be at least 18 years of age;

You may not qualify if:

• 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).
• 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
• Patients who are uncooperative or cannot follow instructions
• 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
• Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;
• Patients with fungal infections (Patients with known or imaging evidence highly suggestive of pulmonary fungal infection)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Zaetta JM, Licht MO, Fisher JS, Avelar RL; Bio-Seal Study Group. A lung biopsy tract plug for reduction of postbiopsy pneumothorax and other complications: results of a prospective, multicenter, randomized, controlled clinical study. J Vasc Interv Radiol. 2010 Aug;21(8):1235-43.e1-3. doi: 10.1016/j.jvir.2010.04.021.

  PMID: 20656223 DERIVED

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Sanjay Gupta, MD
• Organization: UT MD Anderson Cancer Center

srao@mdanderson.org

713-563-7341

Study Officials

• Sanjay Gupta, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 7, 2012
• Results First Posted: July 11, 2011

Record last verified: 2012-08

Locations

US (1)