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NCT Number: NCT04422236

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Gastrectomy Mini Gastric Bypass Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Roux-en-y Gastric Bypass Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Delta vzw

Roeselare, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Device

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

Primary outcomes

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

    Time frame: At index procedure

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

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

    Time frame: At discharge, up to 1 week

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Secondary outcomes

  1. Device performance

    Time frame: At index procedure

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

  2. Device performance

    Time frame: At index procedure

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

  3. Clinical efficacy

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

    Weight loss

  4. Clinical efficacy

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

    Weight loss

  5. Clinical efficacy

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

    Weight loss

  6. Clinical efficacy

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

    Weight loss

  7. Clinical efficacy

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

    Weight loss

  8. Clinical efficacy

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

    Weight loss

  9. Clinical efficacy

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

    Comorbidity

  10. Clinical efficacy

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

    Comorbidity

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Registry information

Acronym: STAP-Delta

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2020
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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