Clinical trial NCT03968757: Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Roux-en-Y Gastric Bypass
Obesity
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

Brief 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. 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.


Eligibility criteria: 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).

Primary outcomes:
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
timeFrame: at index-procedure
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
timeFrame: at discharge, up to 1 week
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
timeFrame: at 6 weeks follow-up
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
timeFrame: at 6 months follow-up
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
timeFrame: at 12 months follow-up
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
timeFrame: at 24 months follow-up
Secondary outcomes:
measure: To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
timeFrame: at index-procedure
measure: To evaluate the performance of the easyEndoTM Universal Linear Cutting
timeFrame: at index-procedure
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at index-procedure
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at discharge, up to 1 week
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 6 weeks follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 6 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 12 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 24 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at discharge, up to 1 week
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 6 weeks follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 6 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 12 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 24 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 6 weeks follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 6 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 12 months follow-up
measure: To evaluate the efficacy of the laparoscopic RYGB surgery
timeFrame: at 24 months follow-up
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
state: West Flanders
Study officials:
References: