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

Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery: a Monocentric Post-market Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03968757

Enrollment

150

Registered

2019-05-30

Start date

2019-07-04

Completion date

2023-06-07

Last updated

2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Roux-en-Y Gastric Bypass

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.

Interventions

DEVICEeasyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	at index-procedure	Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

Secondary

Measure	Time frame	Description
To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)	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.
To evaluate the performance of the easyEndoTM Universal Linear Cutting	at index-procedure	Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).
To evaluate the efficacy of the laparoscopic RYGB surgery	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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026