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Completed

NCT Number: NCT03968757

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Sint-Jan Brugge

Bruges, West Flanders, 8000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age at study entry is at least 18 years.
  • 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.
  • Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
  • Patient has a BMI ≥ 40 kg/m2.

Exclusion criteria

  • Patient is pregnant.
  • History of bariatric surgery.
  • 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).

Treatment and study plan

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Device

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

Primary outcomes

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

    Time frame: at index-procedure

    Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

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

    Time frame: at discharge, up to 1 week

    Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

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

    Time frame: at 6 weeks follow-up

    Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

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

    Time frame: at 6 months follow-up

    Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

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

    Time frame: at 12 months follow-up

    Number of participants with postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

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

    Time frame: at 24 months follow-up

    Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

Secondary outcomes

  1. To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

    Time frame: 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.

  2. To evaluate the performance of the easyEndoTM Universal Linear Cutting

    Time frame: at index-procedure

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

  3. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: 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.

  4. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at discharge, up to 1 week

    Number of participants with post-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.

  5. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 6 weeks follow-up

    Number of participants with post-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.

  6. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 6 months follow-up

    Number of participants with post-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.

  7. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 12 months follow-up

    Number of participants with post-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.

  8. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 24 months follow-up

    Number of participants with post-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.

  9. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at discharge, up to 1 week

    Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.

  10. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 6 weeks follow-up

    Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.

  11. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 6 months follow-up

    Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.

  12. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 12 months follow-up

    Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.

  13. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 24 months follow-up

    Number of participants with bariatric surgery related re-interventions since the laparoscopic RYGB procedure.

  14. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 6 weeks follow-up

    Change of patient's weight

  15. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 6 months follow-up

    Change of patient's weight

  16. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 12 months follow-up

    Change of patient's weight

  17. To evaluate the efficacy of the laparoscopic RYGB surgery

    Time frame: at 24 months follow-up

    Change of patient's weight

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 30, 2019
Registry last updated
Jun 12, 2023

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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