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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968757
• Other study ID #: STAP-D
• Status: Completed
• Start date: July 4, 2019
• Est. completion date: June 7, 2023

Study information

• Verified date: June 2023
• Source: Duomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 7, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Roux-en-Y Gastric Bypass

Intervention

Device:
• easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge	Brugge	West Flanders

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 6 weeks follow-up
Secondary	To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 6 months follow-up
Secondary	To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 12 months follow-up
Secondary	To evaluate the efficacy of the laparoscopic RYGB surgery	Change of patient's weight	at 24 months follow-up