Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
NCT ID: NCT03968757
Last Updated: 2023-06-12
Study Results
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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COMPLETED
150 participants
OBSERVATIONAL
2019-07-04
2023-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Obese patients eligible for laparoscopic RYGB surgery.
easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.
Interventions
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easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
4. Patient has a BMI ≥ 40 kg/m2.
Exclusion Criteria
2. History of bariatric surgery.
3. 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).
18 Years
ALL
No
Sponsors
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Duomed
INDUSTRY
Responsible Party
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Locations
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AZ Sint-Jan Brugge
Bruges, West Flanders, Belgium
Countries
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Other Identifiers
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STAP-D
Identifier Type: -
Identifier Source: org_study_id
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