Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedure

Study Overview
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Brief Summary
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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
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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.

Official 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

Conditions
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Pneumothorax

Intervention / Treatment
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* Device: Bio-Seal Plug


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bio-Seal Group<br>Bio-Seal Plug Implanted | Device: Bio-Seal Plug<br>* Deployment of the Bio-Seal plug in needle track<br>* Other names: Bio-Seal™ Lung Biopsy Tract System;|
| No Intervention: Control Group<br>Control group with no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Chest Tube Placement | A chest tube is the definitive initial treatment of a pneumothorax. | 30 days | 
| Time to Ambulation |  | 30 days | 
| Incidence of Hospital Admissions for Pneumothorax |  | 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. | 30 Day | 
| Number of Participants With Additional Chest X-rays Needed |  | 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. | 30-day | 
| Incidence of Adverse Events | Any treatment emergent adverse events (not considered device related by the investigators). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung biopsy