ObesitySIRIUSNCT04543526
A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
An observational study of Obesity and Roux-en-Y Gastric Bypass, run by Duomed at 2 sites in Belgium.
Trial summary
The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) 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
- What is being tested?
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2021to 30 Nov 2024
- 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 standard laparoscopic or robot-assisted 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
- Patient ≥ 18 years of age at study 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-morbidity.
- Patient has a BMI ≥ 40 kg/m2.
- Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB 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 study protocol or proposed follow-up visits.
- Patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg (ZOL)
Genk
Ziekenhuis Maas en Kempen (ZMK)
Maaseik
About this study
The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.
- Conditions
- Obesity, Roux-en-Y 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 creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery. 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.
Safety - Conversion rate to laparotomy
Number of conversions to laparotomy during the index procedure
Measured: At index procedure.
Safety - Length of stay at the intensive care unit
Number of days at the intensive care unit after the index procedure.
Measured: At index procedure.
Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
The Modified PADSS guarantees safe discharge. PADSS is based on the assessment of 6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output. Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for discharge, provided that the score for vital signs is not lower than 2 and that none of the other five criteria is 0, even if the total score reaches 9.
Measured: At index procedure.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Measured: At index procedure.
Safety - Length of stay at the intensive care unit.
Number of days at the intensive care unit after the index procedure.
Measured: At discharge, up to 1 week.
Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
he Modified PADSS guarantees safe discharge. PADSS is based on the assessment of 6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output. Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for discharge, provided that the score for vital signs is not lower than 2 and that none of the other five criteria is 0, even if the total score reaches 9.
Measured: At discharge, up to 1 week.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Measured: At discharge, up to 1 week.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Measured: Follow-up 1: 1 month after the procedure.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Measured: Follow-up 2: 6 months after the procedure.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Measured: Follow-up 3: 12 months after the procedure
Safety - Number of re-interventions and number of participants with (serious) adverse events
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Measured: Follow-up 4: 24 months after the procedure.
Secondary outcomes (15)
Device performance - Technical success of the surgical procedure performed with the device
Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to laparotomy.
Measured: At index procedure
Device performance - Scoring of operator satisfaction
Scoring of: easy of intra-abdominal device positioning, grasping/climbing force, sharpness of the blades, staple-line formation, device stability, device maneuverability, battery power, device consistency and reliability, ergonomic design, hemostasis. Each of the aforementioned items receives a score from 0 to 4, with 0 indicating that the user is very unsatisfied and 4 indicating that the user is very satisfied.
Measured: At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Assessment of acute post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Assessment of acute post-operative abdominal pain by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: At discharge, up to 1 week
Post-operative pain by means of the Visual Analogue Scale (VAS)
Assessment of the worst post-operative abdominal pain since discharge by means of the VAS, which contains a 0 to 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain.
Measured: Follow-up 1: 1 month after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Measured: Follow-up 1: 1 month after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Measured: Follow-up 2: 6 months after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Measured: Follow-up 3: 12 months after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Food tolerance by means of the food tolerance questionnaire. The food tolerance questionnaire allows to score the patients' satisfaction regarding food intake and food tolerance after bariatric surgery. The patients' interpretation of food intake is scored between 1 (very poor) and 5 (excellent). A cumulative score, varying between 1 and 27 is derived, with 27 representing an excellent food tolerance.
Measured: Follow-up 4: 24 months after the procedure
Post-operative change in weight
Weight loss 1 month after the surgical procedure as compared to the patients' weight at baseline.
Measured: Follow-up 1: 1 month after the procedure
Post-operative change in weight
Weight loss 6 months after the surgical procedure as compared to the patients' weight at baseline.
Measured: Follow-up 2: 6 months after the procedure
Post-operative change in weight
Weight loss 12 months after the surgical procedure as compared to the patients' weight at baseline.
Measured: Follow-up 3: 12 months after the procedure
Post-operative change in weight
Weight loss 24 months after the surgical procedure as compared to the patients' weight at baseline.
Measured: Follow-up 4: 24 months after the procedure
Number of participants with a post-operative change of cormorbidities
Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 12 months after the surgical procedure as compared to the patients' comorbidities at baseline.
Measured: Follow-up 3: 12 months after the procedure
Number of participants with a post-operative change of cormorbidities
Comorbidities (diabetes mellitus, peripheral arterial disease, coronary arterial disease, sleep disordered breathing, hypertension, dyslipidemia, hypercholesterolemia, hypertriglyceridemia, asthma, congestive heart failure, degenerative joint disease, gastroesophageal reflux, chronic obstructive pulmonary disease, use of immunosuppressants) 24 months after the surgical procedure as compared to the patients' comorbidities at baseline.
Measured: Follow-up 4: 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 posted10 Sep 2020
- Study start1 Sep 2021 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Why it stopped: No CEC approval
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Verhelst, Dr., Principal investigator, Ziekenhuis Oost-Limburg (ZOL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543526
- Sponsor's protocol ID
- DM-ZOL-01
- Acronym
- SIRIUS
- Status last verified
- Jul 2021
- First submitted
- 13 Aug 2020
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery
- ClinicalTrials.gov ID
- NCT04543526
- Acronym / sponsor ID
- SIRIUS / DM-ZOL-01
- Conditions
- Obesity, Roux-en-Y Gastric Bypass
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No CEC approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 10 Sep 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 primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery. |
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 standard laparoscopic or robot-assisted 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 (5 listed)
- Patient ≥ 18 years of age at study 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-morbidity.
- Patient has a BMI ≥ 40 kg/m2.
- Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB 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 study protocol or proposed follow-up visits.
- Patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic RYGB 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 creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical. | Device | Obese patients |
Primary outcome
Safety - Conversion rate to laparotomy
Time frame: At index procedure.
Number of conversions to laparotomy during the index procedure
Safety - Length of stay at the intensive care unit
Time frame: At index procedure.
Number of days at the intensive care unit after the index procedure.
Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
Time frame: At index procedure.
The Modified PADSS guarantees safe discharge. PADSS is based on the assessment of 6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output. Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for discharge, provided that the score for vital signs is not lower than 2 and that none of the other five criteria is 0, even if the total score reaches 9.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Time frame: At index procedure.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety - Length of stay at the intensive care unit.
Time frame: At discharge, up to 1 week.
Number of days at the intensive care unit after the index procedure.
Safety - Length of stay in the hospital by the modified Post-Anesthesia Discharge Scoring System (PADSS)
Time frame: At discharge, up to 1 week.
he Modified PADSS guarantees safe discharge. PADSS is based on the assessment of 6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output. Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for discharge, provided that the score for vital signs is not lower than 2 and that none of the other five criteria is 0, even if the total score reaches 9.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Time frame: At discharge, up to 1 week.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Time frame: Follow-up 1: 1 month after the procedure.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Time frame: Follow-up 2: 6 months after the procedure.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Time frame: Follow-up 3: 12 months after the procedure
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
Safety - Number of re-interventions and number of participants with (serious) adverse events
Time frame: Follow-up 4: 24 months after the procedure.
Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.
15 secondary outcomes
Device performance - Technical success of the surgical procedure performed with the device
Time frame: At index procedure
Device performance - Scoring of operator satisfaction
Time frame: At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Time frame: At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Time frame: At discharge, up to 1 week
Post-operative pain by means of the Visual Analogue Scale (VAS)
Time frame: Follow-up 1: 1 month after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Time frame: Follow-up 1: 1 month after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Time frame: Follow-up 2: 6 months after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Time frame: Follow-up 3: 12 months after the procedure
Post-operative food tolerance by means of the food tolerance questionnaire
Time frame: Follow-up 4: 24 months after the procedure
Post-operative change in weight
Time frame: Follow-up 1: 1 month after the procedure
Post-operative change in weight
Time frame: Follow-up 2: 6 months after the procedure
Post-operative change in weight
Time frame: Follow-up 3: 12 months after the procedure
Post-operative change in weight
Time frame: Follow-up 4: 24 months after the procedure
Number of participants with a post-operative change of cormorbidities
Time frame: Follow-up 3: 12 months after the procedure
Number of participants with a post-operative change of cormorbidities
Time frame: Follow-up 4: 24 months after the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- 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.
Hans Verhelst, Dr. principal investigator
Ziekenhuis Oost-Limburg (ZOL)
2 sites 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 2 sites 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: withdrawn, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety - Conversion rate to laparotomy (time frame: At index procedure.). The study lists 11 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 11 Jan 2022.