Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery

June 9, 2023 updated by: Duomed

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.

Study Overview

Status

Status

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

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

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
    • West Flanders
      • Brugge, West Flanders, Belgium, 8000
        • AZ Sint-Jan Brugge

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

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  1. Age at study entry is at least 18 years.
  2. 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.
  3. Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
  4. Patient has a BMI ≥ 40 kg/m2.

Exclusion Criteria:

  1. Patient is pregnant.
  2. History of bariatric surgery.
  3. 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).

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

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 eligible for laparoscopic RYGB surgery.
Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Device for creation of anastomoses during laparoscopic RYGB surgery 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
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.
at index-procedure
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.
at discharge, up to 1 week
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.
at 6 weeks follow-up
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.
at 6 months follow-up
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.
at 12 months follow-up
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.
at 24 months follow-up

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
To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Time Frame: at index-procedure
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.
at index-procedure
To evaluate the performance of the easyEndoTM Universal Linear Cutting
Time Frame: at index-procedure
Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
at index-procedure
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at index-procedure
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.
at index-procedure
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at discharge, up to 1 week
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.
at discharge, up to 1 week
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 6 weeks follow-up
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.
at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 6 months follow-up
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.
at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 12 months follow-up
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.
at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 24 months follow-up
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.
at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at discharge, up to 1 week
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.
at discharge, up to 1 week
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 6 weeks follow-up
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.
at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 6 months follow-up
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.
at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 12 months follow-up
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.
at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 24 months follow-up
Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.
at 24 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 6 weeks follow-up
Change of patient's weight
at 6 weeks follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 6 months follow-up
Change of patient's weight
at 6 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 12 months follow-up
Change of patient's weight
at 12 months follow-up
To evaluate the efficacy of the laparoscopic RYGB surgery
Time Frame: at 24 months follow-up
Change of patient's weight
at 24 months follow-up

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

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 (Actual)

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.
July 4, 2019

Primary Completion (Actual)

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.
April 25, 2023

Study Completion (Actual)

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.
June 7, 2023

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).
May 22, 2019

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.
May 29, 2019

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.
May 30, 2019

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.
June 12, 2023

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.
June 9, 2023

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.
June 1, 2023

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.
  • STAP-D

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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