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Gastric Tissue Stapler Comparison Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04086433
Recruitment Status : Completed
First Posted : September 11, 2019
Results First Posted : June 5, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Standard Bariatrics

Study Description
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Brief Summary:

This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan").

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.


Condition or disease Intervention/treatment
Gastric Resection Device: gastric tissue resection

Study Design
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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastric Tissue Stapler Comparison Study
Actual Study Start Date : July 15, 2019
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 30, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Device: 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
 Device: gastric tissue resection
human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment


Outcome Measures
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Primary Outcome Measures :
  1. Pressure Evaluation [ Time Frame: immediately post operative ]
    Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.

  2. Staple Malformation [ Time Frame: through study completion, anticipate within 2 months ]
    Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Subjects undergoing Laparoscopic Sleeve Gastrectomy
Criteria

Inclusion Criteria:

1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80

Exclusion Criteria:

  1. Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
  2. Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
  3. Stomach damaged during extraction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086433


Locations
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United States, New York
University at Buffalo
Buffalo, New York, United States, 14203
Sponsors and Collaborators
Standard Bariatrics
Investigators
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Principal Investigator: Aaron B Hoffman, MD, FACS University at Buffalo
  Study Documents (Full-Text)

Documents provided by Standard Bariatrics:
Study Protocol  [PDF] June 17, 2019
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: Standard Bariatrics
ClinicalTrials.gov Identifier: NCT04086433    
Other Study ID Numbers: CP-2018-01
First Posted: September 11, 2019    Key Record Dates
Results First Posted: June 5, 2020
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No