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

NCT03239405 | Unknown FDA Device

• 1 other identifier: VIS-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Procedure, Unspecified

Keywords

laparoscopic; sleeve; gastrectomy

Outcome Measures

Primary Outcomes (2)

• Staples Used

  Number of staple loads needed to close stomach

  4 hours for the end of surgery

• Operation time

  Total operation time

  4 hours for the end of surgery

Study Arms (2)

SCS

Treated via suction callibrated system

Device: Suction callibrated system

Bougie

Treated with multiple tubes \& bougie

Interventions

Suction callibrated system DEVICE

One-step suction callibrated SG system

Also known as: Visigi 3D

SCS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals already receiving a laparoscopic sleeve gastrectomy

You may qualify if:

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

Sponsors & Collaborators

• Boehringer Labs LLC: lead
• Rochester General Hospital: collaborator

Study Sites (1)

Rochester General

Rochester, New York, 14621, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 4, 2017
• Study Start: April 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)