Trial Outcomes & Findings for Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy) (NCT NCT05329402)
NCT ID: NCT05329402
Last Updated: 2024-05-02
Results Overview
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. If all staple lines are complete, without air leakage or bleeding, it is judged that the cutting and anastomosis of the device is successful. If there is persistent air leakage and bleeding at the anastomosis site, and conversion to thoracotomy is required, it is judged as device cutting and anastomosis failure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
During surgery
Results posted on
2024-05-02
Participant Flow
30 days
Participant milestones
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
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ECHELON Flex Powered Articulating Endoscopic Linear Cutters
ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
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|---|---|---|
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Overall Study
STARTED
|
80
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84
|
|
Overall Study
COMPLETED
|
79
|
83
|
|
Overall Study
NOT COMPLETED
|
1
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1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=79 Participants
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Lung cancer surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
n=83 Participants
ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
Lung cancer surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
Total
n=162 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
54.95 years
STANDARD_DEVIATION 9.77 • n=79 Participants
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55.33 years
STANDARD_DEVIATION 8.94 • n=83 Participants
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55.14 years
STANDARD_DEVIATION 9.33 • n=162 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=79 Participants
|
51 Participants
n=83 Participants
|
91 Participants
n=162 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=79 Participants
|
32 Participants
n=83 Participants
|
71 Participants
n=162 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
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0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
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79 participants
n=79 Participants
|
83 participants
n=83 Participants
|
162 participants
n=162 Participants
|
|
BMI
|
23.88 kg/m^2
STANDARD_DEVIATION 3.34 • n=79 Participants
|
24.06 kg/m^2
STANDARD_DEVIATION 3.24 • n=83 Participants
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23.97 kg/m^2
STANDARD_DEVIATION 3.28 • n=162 Participants
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PRIMARY outcome
Timeframe: During surgeryThe transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. If all staple lines are complete, without air leakage or bleeding, it is judged that the cutting and anastomosis of the device is successful. If there is persistent air leakage and bleeding at the anastomosis site, and conversion to thoracotomy is required, it is judged as device cutting and anastomosis failure.
Outcome measures
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=79 Participants
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Lung cancer surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
|
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
n=83 Participants
ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
Lung cancer surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
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|---|---|---|
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Number of Participants With Anastomosis Success
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79 Participants
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83 Participants
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Adverse Events
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Serious events: 10 serious events
Other events: 44 other events
Deaths: 0 deaths
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Serious events: 8 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=79 participants at risk
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
|
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
n=83 participants at risk
ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
|
|---|---|---|
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Respiratory, thoracic and mediastinal disorders
pneumothorax
|
2.5%
2/79 • Number of events 2 • 30 days
|
0.00%
0/83 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Right pneumothorax
|
0.00%
0/79 • 30 days
|
2.4%
2/83 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery bleeding
|
1.3%
1/79 • Number of events 1 • 30 days
|
0.00%
0/83 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Aerodermectasia
|
1.3%
1/79 • Number of events 1 • 30 days
|
0.00%
0/83 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic wall lung hernia
|
1.3%
1/79 • Number of events 1 • 30 days
|
0.00%
0/83 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/79 • 30 days
|
1.2%
1/83 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung leak gas
|
1.3%
1/79 • Number of events 1 • 30 days
|
2.4%
2/83 • Number of events 2 • 30 days
|
|
Cardiac disorders
left chest pain
|
0.00%
0/79 • 30 days
|
1.2%
1/83 • Number of events 1 • 30 days
|
|
Nervous system disorders
Acute cerebral infarction
|
1.3%
1/79 • Number of events 1 • 30 days
|
0.00%
0/83 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Left lower lung with residual pulmonary atelectasis
|
1.3%
1/79 • Number of events 1 • 30 days
|
0.00%
0/83 • 30 days
|
|
Eye disorders
Glaucoma
|
1.3%
1/79 • Number of events 1 • 30 days
|
0.00%
0/83 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chylopleura
|
1.3%
1/79 • Number of events 1 • 30 days
|
0.00%
0/83 • 30 days
|
|
Hepatobiliary disorders
Abnormal liver function
|
0.00%
0/79 • 30 days
|
1.2%
1/83 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/79 • 30 days
|
1.2%
1/83 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
n=79 participants at risk
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
|
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
n=83 participants at risk
ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
|
|---|---|---|
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Gastrointestinal disorders
constipation
|
13.9%
11/79 • Number of events 11 • 30 days
|
12.0%
10/83 • Number of events 10 • 30 days
|
|
Gastrointestinal disorders
emesis
|
8.9%
7/79 • Number of events 7 • 30 days
|
8.4%
7/83 • Number of events 7 • 30 days
|
|
Nervous system disorders
aypnia
|
10.1%
8/79 • Number of events 8 • 30 days
|
6.0%
5/83 • Number of events 6 • 30 days
|
|
General disorders
others
|
22.8%
18/79 • 30 days
|
38.6%
32/83 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place