Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy (VS1)

August 1, 2017 updated by: Boehringer Labs LLC
Comparing the operation times and staple loads used between the use of multiple tubes and a bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study we are comparing the cost/savings of using a bougie with a one-step suction callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and staple usage. This study is not affecting the treatment of the patients in any way. The surgeons would be using the devices regardless of the study. We are simply looking at procedure information after the fact.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14621
        • Rochester General

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals already receiving a laparoscopic sleeve gastrectomy

Description

Inclusion Criteria:

  • Patient and surgeon have both agreed that a sleeve gastrectomy is a procedure that they want performed.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SCS
Treated via suction callibrated system
Device: Suction callibrated system
One-step suction callibrated SG system
Other Names:
  • Visigi 3D
Bougie
Treated with multiple tubes & bougie

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staples Used
Time Frame: 4 hours for the end of surgery
Number of staple loads needed to close stomach
4 hours for the end of surgery
Operation time
Time Frame: 4 hours for the end of surgery
Total operation time
4 hours for the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Labs LLC

Collaborators

Rochester General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (Actual)

August 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIS-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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