An observational study in Obesity, Roux-en-Y Gastric Bypass and Gastrectomy, sponsored by Duomed. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.
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 when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by 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 200 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 bariatric surgery. This registry will collect data from 200 laparoscopic bariatric 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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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)
Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: At index procedure
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: At discharge, up to 1 week
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 1: 3 weeks after the procedure
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 2: 8 weeks after the procedure
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 3: 6 months after the procedure
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 4: 12 months after the procedure
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 5: 18 months after the procedure
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Time frame: Follow-up 6: 24 months after the procedure
Device performance
Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.
Time frame: At index procedure
Device performance
Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
Time frame: At index procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 1: 3 weeks after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 2: 8 weeks after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 3: 6 months after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 4: 12 months after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 5: 18 months after the procedure
Clinical efficacy
Weight loss
Time frame: Follow-up 6: 24 months after the procedure
Clinical efficacy
Comorbidity
Time frame: Follow-up 4: 12 months after the procedure
Clinical efficacy
Comorbidity
Time frame: Follow-up 6: 24 months after the procedure
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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