A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-11-30

Brief Summary

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The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.

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Detailed Description

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Conditions

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Obesity Roux-en-Y Gastric Bypass

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese patients

Obese patients eligible for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Intervention Type DEVICE

Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical.

Interventions

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easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient ≥ 18 years of age at study 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-morbidity.
* Patient has a BMI ≥ 40 kg/m2.
* Patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic RYGB 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 study protocol or proposed follow-up visits.
* Patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic RYGB surgery.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No