An observational study in Roux-en-Y Gastric Bypass and Obesity, sponsored by Duomed. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Duomed · Observational
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 150 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Duomed is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 24 months follow-up
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.
Time frame: 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.).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Time frame: at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Time frame: at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Time frame: at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Time frame: at 24 months follow-up
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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