Trial Outcomes & Findings for Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement (NCT NCT04544865)

Last Updated: 2023-12-05

Results Overview

Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line).

Recruitment status

COMPLETED

Study phase

Target enrollment

240 participants

Primary outcome timeframe

From Day 0 (day of surgery) through 70 days post-surgery

Results posted on

2023-12-05

Participant Flow

Participants who planned to have an elective gastric or lung resection surgical procedure were recruited in the study.

Participants were screened anytime during a period of 8 weeks prior to the date of surgery.

Participant milestones

Participant milestones
Measure	Gastric Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Overall Study STARTED	109	131
Overall Study COMPLETED	98	120
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Gastric Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Overall Study Death	0	2
Overall Study Lost to Follow-up	11	7
Overall Study Withdrawal by Subject	0	1
Overall Study Other	0	1

Baseline Characteristics

Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gastric Participants n=109 Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants n=131 Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Total n=240 Participants Total of all reporting groups
Age, Continuous	45.5 Years STANDARD_DEVIATION 11.3 • n=5 Participants	62.8 Years STANDARD_DEVIATION 12.0 • n=7 Participants	54.9 Years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	73 Participants n=7 Participants	164 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	58 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	122 Participants n=7 Participants	221 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	108 Participants n=7 Participants	193 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 0 (day of surgery) through 70 days post-surgery

Population: The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. Here, N' (number of participants analyzed) signifies the participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for specified arm only.

Outcome measures

Outcome measures
Measure	Gastric Participants n=104 Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures Bleeding	0 Participants	—
Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures Leak	1 Participants	—
Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures Stricture	0 Participants	—

PRIMARY outcome

Timeframe: From Day 0 (day of surgery) through 70 days post-surgery

Population: The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. This outcome measure was planned to be analyzed for specified arm only.

Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema).

Outcome measures

Outcome measures
Measure	Gastric Participants n=131 Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days Prolonged air leak	0 Participants	—
Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days Empyema	0 Participants	—

SECONDARY outcome

Timeframe: Day 0 (Intra-surgery)

Population: The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure.

Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported.

Outcome measures

Outcome measures
Measure	Gastric Participants n=637 Study devices Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants n=598 Study devices Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Number of Study Devices Replaced During Surgery Slipping	0 Replaced study devices	3 Replaced study devices
Number of Study Devices Replaced During Surgery Bunching	0 Replaced study devices	1 Replaced study devices
Number of Study Devices Replaced During Surgery Not Loaded Properly	7 Replaced study devices	3 Replaced study devices
Number of Study Devices Replaced During Surgery Other - Preloaded Wrong Color Cartridge	1 Replaced study devices	0 Replaced study devices
Number of Study Devices Replaced During Surgery Other- SLR Added Before Cartridge	1 Replaced study devices	0 Replaced study devices
Number of Study Devices Replaced During Surgery Other- Dropped on the Ground	1 Replaced study devices	0 Replaced study devices

SECONDARY outcome

Timeframe: Day 0 (Intra-surgery)

Population: The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies the number of investigators who responded to device questionnaire.

Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response was ranged from 1 to 5 where 1=strongly disagree, 2=slightly disagree,3=neutral, 4=slightly agree, 5= strongly agree, where the higher response signified good experience on the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and 5th procedure were reported.

Outcome measures

Outcome measures
Measure	Gastric Participants n=12 Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants n=18 Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Experienced less buttress manipulation and movement compared to previous buttress: Strongly disagree	0 Investigators	1 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Experienced less buttress manipulation and movement compared to previous buttress: Slightly disagree	0 Investigators	1 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Experienced less buttress manipulation and movement compared to previous buttress: Neutral	3 Investigators	1 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Experienced less buttress manipulation and movement compared to previous buttress: Slightly agree	6 Investigators	2 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Experienced less buttress manipulation and movement compared to previous buttress: Strongly agree	3 Investigators	13 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Greater confidence that SLR buttress deliver best outcomes compared to previous:Slightly disagree	3 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Greater confidence that SLR buttress deliver best outcomes compared to previous: Neutral	6 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Greater confidence that SLR buttress deliver best outcomes compared to previous: Slightly agree	2 Investigators	2 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly agree	1 Investigators	16 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback SLR setup simplifies concerns compared to previous buttress product: Strongly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback SLR setup simplifies concerns compared to previous buttress product: Slightly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback SLR setup simplifies concerns compared to previous buttress product: Neutral	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback SLR setup simplifies concerns compared to previous buttress product: Slightly agree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback SLR setup simplifies concerns compared to previous buttress product: Strongly agree	12 Investigators	18 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Surgical staff experienced less frustration with SLR compared to previous buttress:Strongly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Surgical staff experienced less frustration with SLR compared to previous buttress:Slightly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Surgical staff experienced less frustration with SLR compared to previous buttress: Neutral	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Surgical staff experienced less frustration with SLR compared to previous buttress: Slightly agree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Surgical staff experienced less frustration with SLR compared to previous buttress: Strongly agree	12 Investigators	18 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Foresee less waste of SLR compared to the previous buttress: Strongly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Foresee less waste of SLR compared to the previous buttress: Slightly disagree	1 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Foresee less waste of SLR compared to the previous buttress: Neutral	1 Investigators	2 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Foresee less waste of SLR compared to the previous buttress: Slightly agree	4 Investigators	2 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Foresee less waste of SLR compared to the previous buttress: Strongly agree	6 Investigators	14 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Likely to recommend to a colleague: Strongly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Likely to recommend to a colleague: Slightly disagree	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Likely to recommend to a colleague: Neutral	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Likely to recommend to a colleague: Slightly agree	5 Investigators	2 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback Likely to recommend to a colleague: Strongly agree	7 Investigators	16 Investigators

SECONDARY outcome

Timeframe: Day 0 (Intra-surgery)

Population: The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure. Here, N' (number of participants analyzed) signifies the number of investigators who responded to device questionnaire.

Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions "satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device" and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and fifth procedure were reported.

Outcome measures

Outcome measures
Measure	Gastric Participants n=12 Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants n=18 Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of operative flow compared to previous device: Very dissatisfied	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of operative flow compared to previous device: Dissatisfied	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of operative flow compared to previous device: Neither dissatisfied nor satisfied	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of operative flow compared to previous device: Satisfied	3 Investigators	2 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of operative flow compared to previous device: Very satisfied	9 Investigators	16 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of manipulation and repositioning compared to previous device:Very dissatisfied	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of manipulation and repositioning compared to previous device: Dissatisfied	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of manipulation and repositioning compared to previous device: NDNS	0 Investigators	0 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of manipulation and repositioning compared to previous device: Satisfied	1 Investigators	3 Investigators
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback Satisfaction of manipulation and repositioning compared to previous device: Very satisfied	11 Investigators	15 Investigators

Adverse Events

Gastric Participants

Serious events: 8 serious events

Other events: 74 other events

Deaths: 0 deaths

Thoracic Participants

Serious events: 18 serious events

Other events: 116 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

SENIOR DIRECTOR OF CLINICAL AFFAIRS

Ethicon Endo-Surgery

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
Publication restrictions are in place

Restriction type: OTHER

Measure	Gastric Participants n=109 participants at risk Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.	Thoracic Participants n=131 participants at risk Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days.
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	2.3% 3/131 • Number of events 3 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	1.5% 2/131 • Number of events 2 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Nausea	1.8% 2/109 • Number of events 2 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Dysphagia	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Gastric Fistulas	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Gastric perforation	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Gastric ulcer	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Inguinal hernia	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Gastrointestinal disorders Vomiting	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Infections and infestations Pneumonia	1.8% 2/109 • Number of events 2 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	1.5% 2/131 • Number of events 2 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Infections and infestations Bacteraemia	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Infections and infestations Fungaemia	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Infections and infestations Lung infection	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Infections and infestations Pneumonia viral	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Infections and infestations Postoperative wound infection	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Cardiac disorders Atrial fibrillation	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	1.5% 2/131 • Number of events 2 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Cardiac disorders Cardiac failure acute	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Cardiac disorders Myocardial infarction	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Cardiac disorders Pericardial effusion	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Injury, poisoning and procedural complications Drain site complication	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Injury, poisoning and procedural complications Gastrointestinal anastomotic stenosis	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Metabolism and nutrition disorders Dehydration	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Nervous system disorders Carotid artery stenosis	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Nervous system disorders Cerebrovascular accident	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Hepatobiliary disorders Portal vein thrombosis	1.8% 2/109 • Number of events 2 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
General disorders Chest pain	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Psychiatric disorders Mental status changes	0.00% 0/109 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.76% 1/131 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.
Renal and urinary disorders Acute kidney injury	0.92% 1/109 • Number of events 1 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.	0.00% 0/131 • From Day 0 (Day of surgery) up to end of the study (2 years 4 months) The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure.