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The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powered vascular stapler | Experimental | Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler | Device | Powered Vascular Stapler used on vessels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intra-Operative Hemostatic Interventions | Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open). | Intra-Operative |
| Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS:
No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection). | Post-op through 4 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keneng Chen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Shugeng Gao | Cancer Institute and Hospital, Chinese Academy of Medical Services | Principal Investigator |
| Hu Jian | The first affiliated hospital Zhejiang University/Hangzhou | Principal Investigator |
| Li Jian | Beijing Friendship hospital/Hangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
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This was a single-arm study where all enrolled patients would have their surgery performed using the powered vascular stapler.
Recruitment occurred from January 2017 to April 2017 across 4 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Powered Vascular Stapler | All enrolled subjects who had surgery performed using the powered vascular stapler. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Powered Vascular Stapler | All enrolled subjects who had surgery performed using the powered vascular stapler. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions. |
| 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 Intra-Operative Hemostatic Interventions | Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open). | All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions | Posted | Number | 95% Confidence Interval | Percentage of vessel transections | Intra-Operative | Vessel Transections | Vessel Transections |
|
Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Powered Vascular Stapler | All enrolled subjects who had surgery performed using the powered vascular stapler. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
This was a single arm study with a limited sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Schwiers | Ethicon | 513-337-1172 | mschwier@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2016 | Jun 1, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2017 | Jun 1, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions. | Count of Participants | Participants |
|
| Race (NIH/OMB) | All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions. | Count of Participants | Participants |
|
| Region of Enrollment | All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions. | Count of Participants | Participants |
|
|
|
| Primary | Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS:
No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection). | All enrolled subjects in whom a procedure was started. | Posted | Number | 95% Confidence Interval | Percentage | Post-op through 4 week follow-up |
|
|
|
| 0 |
| 50 |
| 5 |
| 50 |
| 12 |
| 50 |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |