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Active, not recruitingNCT04422236STAP-DeltaUpdated Apr 1, 2025

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

An observational study in Obesity, Roux-en-Y Gastric Bypass and Gastrectomy, sponsored by Duomed. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Duomed · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Roux-en-Y Gastric Bypass
  • Gastrectomy
  • Mini Gastric Bypass
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (actual)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • Obese patients eligible for laparoscopic bariatric surgery

    Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

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.

05

What researchers measure

Primary outcomes

  1. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: At index procedure

  2. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: At discharge, up to 1 week

  3. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: Follow-up 1: 3 weeks after the procedure

  4. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: Follow-up 2: 8 weeks after the procedure

  5. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: Follow-up 3: 6 months after the procedure

  6. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: Follow-up 4: 12 months after the procedure

  7. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: Follow-up 5: 18 months after the procedure

  8. To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.

    Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

    Time frame: Follow-up 6: 24 months after the procedure

Secondary outcomes

  1. Device performance

    Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.

    Time frame: At index procedure

  2. Device performance

    Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).

    Time frame: At index procedure

  3. Clinical efficacy

    Weight loss

    Time frame: Follow-up 1: 3 weeks after the procedure

  4. Clinical efficacy

    Weight loss

    Time frame: Follow-up 2: 8 weeks after the procedure

  5. Clinical efficacy

    Weight loss

    Time frame: Follow-up 3: 6 months after the procedure

  6. Clinical efficacy

    Weight loss

    Time frame: Follow-up 4: 12 months after the procedure

  7. Clinical efficacy

    Weight loss

    Time frame: Follow-up 5: 18 months after the procedure

  8. Clinical efficacy

    Weight loss

    Time frame: Follow-up 6: 24 months after the procedure

  9. Clinical efficacy

    Comorbidity

    Time frame: Follow-up 4: 12 months after the procedure

  10. Clinical efficacy

    Comorbidity

    Time frame: Follow-up 6: 24 months after the procedure

06

Study locations

1 site
  • AZ Delta vzw
    Roeselare, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04422236
Lead sponsor
Duomed
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
Sep 28, 2020
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Apr 1, 2025

Study contacts

Bart Smet, Dr.
principal investigator · AZ Delta vzw

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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