Clinical trial NCT04422236: A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
Official title: A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Roux-en-Y Gastric Bypass
Gastrectomy
Mini Gastric Bypass
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 200
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 bariatric surgery. This registry will collect data from 200 laparoscopic bariatric 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 when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years of age at registry 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-morbidities.
* Patient has a BMI ≥ 40 kg/m2.
* Patient is eligible for laparoscopic bariatric 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 registry protocol or proposed follow-up visits.
* Patient has a contra-indication for laparoscopic bariatric surgery.

Primary outcomes:
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: At index procedure
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: At discharge, up to 1 week
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: Follow-up 1: 3 weeks after the procedure
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: Follow-up 2: 8 weeks after the procedure
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: Follow-up 3: 6 months after the procedure
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: Follow-up 4: 12 months after the procedure
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: Follow-up 5: 18 months after the procedure
measure: To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.
timeFrame: Follow-up 6: 24 months after the procedure
Secondary outcomes:
measure: Device performance
timeFrame: At index procedure
measure: Device performance
timeFrame: At index procedure
measure: Clinical efficacy
timeFrame: Follow-up 1: 3 weeks after the procedure
measure: Clinical efficacy
timeFrame: Follow-up 2: 8 weeks after the procedure
measure: Clinical efficacy
timeFrame: Follow-up 3: 6 months after the procedure
measure: Clinical efficacy
timeFrame: Follow-up 4: 12 months after the procedure
measure: Clinical efficacy
timeFrame: Follow-up 5: 18 months after the procedure
measure: Clinical efficacy
timeFrame: Follow-up 6: 24 months after the procedure
measure: Clinical efficacy
timeFrame: Follow-up 4: 12 months after the procedure
measure: Clinical efficacy
timeFrame: Follow-up 6: 24 months after the procedure
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta vzw
Study officials:
affiliation: AZ Delta vzw
name: Bart Smet, Dr.
role: PRINCIPAL_INVESTIGATOR
References: