ObesitySTAP-DeltaNCT04422236
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
An observational study of Obesity and Roux-en-Y Gastric Bypass, run by Duomed at 1 site in Belgium.
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 when used to create anastomoses during laparoscopic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Roux-en-Y Gastric Bypass, Gastrectomy
- What is being tested?
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Sep 2020to 31 May 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- Patient ≥ 18 years of age at registry entry.
- Patient and investigator signed and dated the informed consent form prior to the index-procedure.
- Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.
- Patient has a BMI ≥ 40 kg/m2.
- Patient is eligible for laparoscopic bariatric surgery.
Who cannot join
- Patient is unable / unwilling to provide informed consent.
- Patient has a history of bariatric surgery.
- Patient is unable to comply with the registry protocol or proposed follow-up visits.
- Patient has a contra-indication for laparoscopic bariatric surgery.
Trial locations and contacts
1 site in 1 country.
About this 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 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.
- Conditions
- Obesity, Roux-en-Y Gastric Bypass, Gastrectomy, Mini Gastric Bypass
- Being tested
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)Device
Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients eligible for laparoscopic bariatric surgery | Not described Receives: Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up 6: 24 months after the procedure
Secondary outcomes (10)
Device performance
Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.
Measured: At index procedure
Device performance
Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
Measured: At index procedure
Clinical efficacy
Weight loss
Measured: Follow-up 1: 3 weeks after the procedure
Clinical efficacy
Weight loss
Measured: Follow-up 2: 8 weeks after the procedure
Clinical efficacy
Weight loss
Measured: Follow-up 3: 6 months after the procedure
Clinical efficacy
Weight loss
Measured: Follow-up 4: 12 months after the procedure
Clinical efficacy
Weight loss
Measured: Follow-up 5: 18 months after the procedure
Clinical efficacy
Weight loss
Measured: Follow-up 6: 24 months after the procedure
Clinical efficacy
Comorbidity
Measured: Follow-up 4: 12 months after the procedure
Clinical efficacy
Comorbidity
Measured: Follow-up 6: 24 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start28 Sep 2020
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Smet, Dr., Principal investigator, AZ Delta vzw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422236
- Sponsor's protocol ID
- DM-Delta-01
- Acronym
- STAP-Delta
- Status last verified
- Mar 2025
- First submitted
- 25 May 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04422236
- Acronym / sponsor ID
- STAP-Delta / DM-Delta-01
- Conditions
- Obesity, Roux-en-Y Gastric Bypass, Gastrectomy, Mini Gastric Bypass
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients eligible for laparoscopic bariatric surgery | – | Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (5 listed)
- Patient ≥ 18 years of age at registry entry.
- Patient and investigator signed and dated the informed consent form prior to the index-procedure.
- Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.
- Patient has a BMI ≥ 40 kg/m2.
- Patient is eligible for laparoscopic bariatric surgery.
Key exclusion criteria (4 listed)
- Patient is unable / unwilling to provide informed consent.
- Patient has a history of bariatric surgery.
- Patient is unable to comply with the registry protocol or proposed follow-up visits.
- Patient has a contra-indication for laparoscopic bariatric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Obese patients eligible for laparoscopic bariatric surgery |
Primary outcome
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: At index procedure
Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: At discharge, up to 1 week
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: Follow-up 1: 3 weeks after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: Follow-up 2: 8 weeks after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: Follow-up 3: 6 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: Follow-up 4: 12 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: Follow-up 5: 18 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
Time frame: Follow-up 6: 24 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
10 secondary outcomes
Device performance
Time frame: At index procedure
Device performance
Time frame: At index procedure
Clinical efficacy
Time frame: Follow-up 1: 3 weeks after the procedure
Clinical efficacy
Time frame: Follow-up 2: 8 weeks after the procedure
Clinical efficacy
Time frame: Follow-up 3: 6 months after the procedure
Clinical efficacy
Time frame: Follow-up 4: 12 months after the procedure
Clinical efficacy
Time frame: Follow-up 5: 18 months after the procedure
Clinical efficacy
Time frame: Follow-up 6: 24 months after the procedure
Clinical efficacy
Time frame: Follow-up 4: 12 months after the procedure
Clinical efficacy
Time frame: Follow-up 6: 24 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Smet, Dr. principal investigator
AZ Delta vzw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Roux-en-Y Gastric Bypass, run by Duomed at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery. (time frame: At index procedure). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.