Pneumothorax
Conditions
Keywords
lung biopsy
Brief summary
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
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.
Interventions
DEVICEBio-Seal Plug
Deployment of the Bio-Seal plug in needle track
Sponsors
Angiotech Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Treatment Success | 30 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Ambulation | 30 days | — |
| Incidence of Hospital Admissions for Pneumothorax | 30 day | — |
| Incidence of Adverse Events Related to the Procedure and Device Effects | 30 Day | Anticipated, device-related adverse events that were defined in the original protocol. |
| Incidence of Chest Tube Placement | 30 days | A chest tube is the definitive initial treatment of a pneumothorax. |
| Participants Discharged Beyond Hospital's Standard of Care | 30-day | 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. |
| Incidence of Adverse Events | 30 days | Any treatment emergent adverse events (not considered device related by the investigators). |
| Number of Participants With Additional Chest X-rays Needed | 30 day | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bio-Seal Group Bio-Seal Plug Implanted | 170 |
| Control Group Control group with no intervention | 169 |
| Total | 339 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 6 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Lung resection prior to study completion | 7 | 7 |
| Overall Study | Non-compliance | 1 | 2 |
| Overall Study | Not stated | 1 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 8 |
Baseline characteristics
| Characteristic | Bio-Seal Group | Control Group | Total |
|---|---|---|---|
| Age Continuous | 66.1 Years STANDARD_DEVIATION 11.47 | 67.2 Years STANDARD_DEVIATION 12.38 | 66.7 Years STANDARD_DEVIATION 11.93 |
| History of Smoking No | 25 Participants | 23 Participants | 48 Participants |
| History of Smoking Yes | 145 Participants | 146 Participants | 291 Participants |
| Sex: Female, Male Female | 92 Participants | 75 Participants | 167 Participants |
| Sex: Female, Male Male | 78 Participants | 94 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 170 | 90 / 169 |
| serious Total, serious adverse events | 1 / 170 | 2 / 169 |
Outcome results
Primary
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).
Time frame: 30 days
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bio-Seal Group | Incidence Rate of Treatment Success | 126 participants |
| Control Group | Incidence Rate of Treatment Success | 94 participants |
Secondary
Incidence of Adverse Events
Any treatment emergent adverse events (not considered device related by the investigators).
Time frame: 30 days
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bio-Seal Group | Incidence of Adverse Events | 31 participants |
| Control Group | Incidence of Adverse Events | 36 participants |
Secondary
Incidence of Adverse Events Related to the Procedure and Device Effects
Anticipated, device-related adverse events that were defined in the original protocol.
Time frame: 30 Day
Population: Intent to Treat Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bio-Seal Group | Incidence of Adverse Events Related to the Procedure and Device Effects | 43 participants |
| Control Group | Incidence of Adverse Events Related to the Procedure and Device Effects | 74 participants |
Secondary
Incidence of Chest Tube Placement
A chest tube is the definitive initial treatment of a pneumothorax.
Time frame: 30 days
Population: Intent to treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bio-Seal Group | Incidence of Chest Tube Placement | 6 participants |
| Control Group | Incidence of Chest Tube Placement | 18 participants |
Secondary
Incidence of Hospital Admissions for Pneumothorax
Time frame: 30 day
Population: Intent to treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bio-Seal Group | Incidence of Hospital Admissions for Pneumothorax | 16 participants |
| Control Group | Incidence of Hospital Admissions for Pneumothorax | 23 participants |
Secondary
Number of Participants With Additional Chest X-rays Needed
Time frame: 30 day
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bio-Seal Group | Number of Participants With Additional Chest X-rays Needed | 29 participants |
| Control Group | Number of Participants With Additional Chest X-rays Needed | 52 participants |
Secondary
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.
Time frame: 30-day
Population: Intent to Treat Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bio-Seal Group | Participants Discharged Beyond Hospital's Standard of Care | 8 participants |
| Control Group | Participants Discharged Beyond Hospital's Standard of Care | 18 participants |
Secondary
Time to Ambulation
Time frame: 30 days
Population: Intent to Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bio-Seal Group | Time to Ambulation | 3.3 Hours | Standard Deviation 4.63 |
| Control Group | Time to Ambulation | 3.8 Hours | Standard Deviation 6.29 |