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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

Tracking Information
First Submitted Date July 29, 2019
First Posted Date September 11, 2019
Results First Submitted Date May 21, 2020
Results First Posted Date June 5, 2020
Last Update Posted Date June 25, 2020
Actual Study Start Date July 15, 2019
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gastric Tissue Stapler Comparison Study
Official Title Gastric Tissue Stapler Comparison Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects undergoing Laparoscopic Sleeve Gastrectomy
Condition Gastric Resection
Intervention Device: gastric tissue resection
human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Study Groups/Cohorts
  • 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
    Intervention: Device: gastric tissue resection
  • 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
    Intervention: Device: gastric tissue resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 21, 2020)		 36
Original Estimated Enrollment
 (submitted: September 9, 2019)		 75
Actual Study Completion Date October 30, 2019
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04086433
Other Study ID Numbers CP-2018-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Standard Bariatrics
Original Responsible Party Same as current
Current Study Sponsor Standard Bariatrics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Aaron B Hoffman, MD, FACS University at Buffalo
PRS Account Standard Bariatrics
Verification Date June 2020