Study Results
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View full resultsBasic Information
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COMPLETED
36 participants
OBSERVATIONAL
2019-07-15
2019-10-30
Brief Summary
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The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm A - Echelon Stapler
Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation
gastric tissue resection
human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Arm B - Titan Stapler
Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation
gastric tissue resection
human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Interventions
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gastric tissue resection
human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
3. Stomach damaged during extraction
18 Years
80 Years
ALL
No
Sponsors
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Standard Bariatrics
INDUSTRY
Responsible Party
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Principal Investigators
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Aaron B Hoffman, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
Locations
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University at Buffalo
Buffalo, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CP-2018-01
Identifier Type: -
Identifier Source: org_study_id
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