Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery

Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery: a Monocentric Post-market Observational Study

The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Study Overview

• Status: Completed
• Conditions: Obesity; Roux-en-Y Gastric Bypass
• Intervention / Treatment: Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Belgium
  • West Flanders
    • Brugge, West Flanders, Belgium, 8000
      • AZ Sint-Jan Brugge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Obese patients eligible for laparoscopic RYGB surgery. This registry will collect data from 150 laparoscopic RYGB procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).

Description

Inclusion Criteria:

1. Age at study entry is at least 18 years.
2. Patient must sign and date the informed consent form prior to the index-procedure. If the patient is not able to give informed consent, a legally authorized representative must give informed consent on his/her behalf.
3. Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
4. Patient has a BMI ≥ 40 kg/m2.

Exclusion Criteria:

1. Patient is pregnant.
2. History of bariatric surgery.
3. Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese patients eligible for laparoscopic RYGB surgery.	Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical); Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.	at index-procedure
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.	at discharge, up to 1 week
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.	at 6 weeks follow-up
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.	at 6 months follow-up
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	Number of participants with postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.	at 12 months follow-up
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.	at 24 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	Number of procedures with technical success, defined as laparoscopic Roux-en-Y gastric bypass formation as intended without technical difficulties and without conversion to open laparotomy.	at index-procedure
To evaluate the performance of the easyEndoTM Universal Linear Cutting	Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).	at index-procedure
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with peri-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death.	at index-procedure
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death.	at discharge, up to 1 week
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death.	at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death.	at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death.	at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with post-operative complications such as but not limited to: peritonitis, anastomotic stenosis/stricture, internal hernia, small bowel obstruction, ulceration, fistula formation, ventral hernia, iatrogenic splenic injury, wound infection, pneumonia, pulmonary embolism, kidney failure, gallstones, arrhythmia, stroke, infarction, death.	at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.	at discharge, up to 1 week
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.	at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.	at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.	at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.	at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 24 months follow-up

Collaborators and Investigators

• Sponsor: Duomed

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STAP-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No