Roux-en-Y Gastric BypassNCT03968757
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
An observational study of Roux-en-Y Gastric Bypass and Obesity, 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 used in laparoscopic RYGB surgery to create anastomoses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Roux-en-Y Gastric Bypass, Obesity
- What is being tested?
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jul 2019to 7 Jun 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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).
Who may be able to join
- Age at study entry is at least 18 years.
- 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.
- Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
- Patient has a BMI ≥ 40 kg/m2.
Who cannot join
- Patient is pregnant.
- History of bariatric surgery.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Roux-en-Y Gastric Bypass, Obesity
- 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
Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients eligible for laparoscopic RYGB 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)
Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 24 months follow-up
Secondary outcomes (17)
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.
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Measured: at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Measured: at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Measured: at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Change of patient's weight
Measured: at 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start4 Jul 2019
- Primary completion25 Apr 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Roux-en-Y Gastric BypassStudies 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
- 150 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968757
- Sponsor's protocol ID
- STAP-D
- Status last verified
- Jun 2023
- First submitted
- 22 May 2019
- Last updated
- 12 Jun 2023
- 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 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03968757
- Acronym / sponsor ID
- STAP-D
- Conditions
- Roux-en-Y Gastric Bypass, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 30 May 2019 (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 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 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 RYGB 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 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).
Key inclusion criteria (4 listed)
- Age at study entry is at least 18 years.
- 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.
- Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
- Patient has a BMI ≥ 40 kg/m2.
Key exclusion criteria (3 listed)
- Patient is pregnant.
- History of bariatric surgery.
- 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).
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)Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical. | Device | Obese patients eligible for laparoscopic RYGB surgery. |
Primary outcome
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time frame: at index-procedure
Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time frame: at discharge, up to 1 week
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time frame: at 6 weeks follow-up
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time frame: at 6 months follow-up
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time frame: at 12 months follow-up
Number of participants with postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time frame: at 24 months follow-up
Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.
17 secondary outcomes
To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time frame: at index-procedure
To evaluate the performance of the easyEndoTM Universal Linear Cutting
Time frame: at index-procedure
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at index-procedure
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at discharge, up to 1 week
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at discharge, up to 1 week
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time frame: at 24 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Roux-en-Y Gastric Bypass and Obesity, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 12 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) (time frame: at index-procedure). The study lists 6 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 12 Jun 2023.