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 (SIRIUS)

January 7, 2022 updated by: Duomed
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg (ZOL)
      • Maaseik, Belgium
        • Ziekenhuis Maas en Kempen (ZMK)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Obese patients
Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety - Conversion rate to laparotomy
Time Frame: At index procedure.
Number of conversions to laparotomy during the index procedure
At 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.
At 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.
At index procedure.
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.
At index procedure.
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.
At discharge, up to 1 week.
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.
At discharge, up to 1 week.
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.
At discharge, up to 1 week.
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.
Follow-up 1: 1 month after the procedure.
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.
Follow-up 2: 6 months after the procedure.
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.
Follow-up 3: 12 months after the procedure
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.
Follow-up 4: 24 months after the procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with a post-operative change of cormorbidities
Time Frame: Follow-up 3: 12 months after the procedure
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.
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
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.
Follow-up 4: 24 months after the procedure
Device performance - Technical success of the surgical procedure performed with the device
Time Frame: At index procedure
Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to laparotomy.
At index procedure
Device performance - Scoring of operator satisfaction
Time Frame: At index procedure
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.
At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Time Frame: At index procedure
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.
At index procedure
Post-operative pain by means of the Visual Analogue Scale (VAS)
Time Frame: At discharge, up to 1 week
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Follow-up 4: 24 months after the procedure
Post-operative change in weight
Time Frame: Follow-up 1: 1 month after the procedure
Weight loss 1 month after the surgical procedure as compared to the patients' weight at baseline.
Follow-up 1: 1 month after the procedure
Post-operative change in weight
Time Frame: Follow-up 2: 6 months after the procedure
Weight loss 6 months after the surgical procedure as compared to the patients' weight at baseline.
Follow-up 2: 6 months after the procedure
Post-operative change in weight
Time Frame: Follow-up 3: 12 months after the procedure
Weight loss 12 months after the surgical procedure as compared to the patients' weight at baseline.
Follow-up 3: 12 months after the procedure
Post-operative change in weight
Time Frame: Follow-up 4: 24 months after the procedure
Weight loss 24 months after the surgical procedure as compared to the patients' weight at baseline.
Follow-up 4: 24 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duomed

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hans Verhelst, Dr., Ziekenhuis Oost-Limburg (ZOL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DM-ZOL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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