A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04422236

Acronym

STAP-Delta

Enrollment

200

Registered

2020-06-09

Start date

2020-09-28

Completion date

2025-05-31

Last updated

2025-04-01

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

Conditions

Gastrectomy, Mini Gastric Bypass, 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 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.

Interventions

DEVICEeasyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric 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

* 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.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.	At index procedure	Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Secondary

Measure	Time frame	Description
Device performance	At index procedure	Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.
Clinical efficacy	Follow-up 1: 3 weeks after the procedure	Weight loss

Countries

Belgium

Outcome results

None listed

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