Comparing the Cost Savings Potential of Orogastric Tubes... | NCT03239405

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

NCT03239405

Sponsor

Boehringer Labs LLC

Status

Unknown status

Last Update Posted

Aug 4, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Surgical Procedure, Unspecified

Interventions

Suction callibrated system

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Dec 1, 2017Estimated

Completion Date

Dec 1, 2017Estimated

First Submitted Date

Jul 27, 2017

First Submission Date that Met QC Criteria

Aug 1, 2017

First Posted Date

Aug 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2017

Last Update Posted Date

Aug 4, 2017Actual

Name	Class
Rochester General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCS		Treated via suction callibrated system	Device: Suction callibrated system
Bougie		Treated with multiple tubes & bougie

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Suction callibrated system	Device	One-step suction callibrated SG system	SCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals already receiving a laparoscopic sleeve gastrectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rochester General		Rochester	New York	14621	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Results will be published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided