Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIAâ„¢ Stapler with ENDO GIAâ„¢ SULU with TRI-STAPLEâ„¢ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENDO GIAâ„¢ Stapler with TRI-STAPLEâ„¢ Technology | Experimental | Single arm study, all patients will receive the study device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDO GIAâ„¢ Stapler with TRI-STAPLEâ„¢ Technology | Device | All patients will have surgery with ENDO GIAâ„¢ Stapler with TRI-STAPLEâ„¢ Technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Prolonged Air Leaks | Defined as > 5 days by the Society for Thoracic Surgery | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Air Leaks | As recorded on the air leak log. | Day 30 |
| Duration of Air Leak | Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert McKenna, MD | Cedar Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedar Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Advocate Christ Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ENDO GIAâ„¢ Stapler With TRI-STAPLEâ„¢ Technology | Single arm study, all patients will receive the study device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
128 subjects were screened for enrollment. 50 subjects were consented, enrolled and treated. There were 78 screen failures. 3 subjects were excluded from analysis, leaving 47 eligible subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ENDO GIAâ„¢ Stapler With TRI-STAPLEâ„¢ Technology | Single arm study, all patients will receive the study device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Prolonged Air Leaks | Defined as > 5 days by the Society for Thoracic Surgery | Posted | Number | participants | Day 30 |
|
|
Adverse events were collected up to 30 days post surgery.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENDO GIAâ„¢ Stapler With TRI-STAPLEâ„¢ Technology | Single arm study, all patients will receive the study device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (14.1) | Atrial Fibrillation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiomegaly | Cardiac disorders | MedDRA (14.1) | Cardiomegaly |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noreen Fahey | Covidien | 203-821-4716 | noreen.fahey@covidien.com |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 30 |
| Length of Hospital Stay | Approximately Day 6 |
| Duration of Chest Tube Following Surgery | Chest tube duration was calculated as removal date - placement date + 1 | Approximately Day 5 |
| Incidence of Serosal Tearing | Day 30 |
| Oak Lawn |
| Illinois |
| 60453 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| years |
|
| Gender | Number | participants |
|
| Race (NIH/OMB) | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Incidence of Air Leaks | As recorded on the air leak log. | Posted | Number | number of patients with air leaks | Day 30 |
|
|
|
| Secondary | Duration of Air Leak | Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge. | Posted | Mean | Standard Deviation | days | Day 30 |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | days | Approximately Day 6 |
|
|
|
| Secondary | Duration of Chest Tube Following Surgery | Chest tube duration was calculated as removal date - placement date + 1 | Posted | Mean | Standard Deviation | days | Approximately Day 5 |
|
|
|
| Secondary | Incidence of Serosal Tearing | Posted | Number | 95% Confidence Interval | participants | Day 30 |
|
|
|
| 10 |
| 47 |
| 46 |
| 47 |
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Tachycardia |
|
| Colitis Ischaemic | Gastrointestinal disorders | MedDRA (14.1) | Mild Ischemic Colitis |
|
| Gastritis | Gastrointestinal disorders | MedDRA (14.1) | Mild Gastritis |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Pneumonia |
|
| Tooth Abscess | Infections and infestations | MedDRA (14.1) | Abscessed Tooth |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (14.1) | Stroke |
|
| Bronchopleural Fistula | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Bronchopleural Fistula |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Hemothorax |
|
| Hepatic Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Hepatic Hydrothorax |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Hypercapnia |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Aspiration Pneumonia |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Left Pneumothorax |
|
| Pulmonary Air Leakage | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Peristent Pulmonary Air Leak |
|
| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Subcutaneous Emphysema |
|
| Hypotension | Vascular disorders | MedDRA (14.1) | Hypotension |
|
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Tachycardia |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Urinary Tract Infection |
|
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA (14.1) | Incision Site Pain |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (14.1) | Procedural Pain |
|
| Neuralgia | Nervous system disorders | MedDRA (14.1) | Neuralgia |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Atelectasis |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Cough |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Dyspnea |
|
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Hydropneumothorax |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Hypoxia |
|
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Lung Infiltration |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Pleural Effusion |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Pneumothorax |
|
| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Subcutaneous Emphysema |
|
| Hypotension | Vascular disorders | MedDRA (14.1) | Hypotension |
|
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |