Observational Study Comparing Gastric Calibration Tubes | NCT04170400

Studies
Observational Study Comparing Gastric Calibration Tubes

NCT04170400

Sponsor

AZ Sint-Jan AV

Status

Unknown status

Last Update Posted

Nov 21, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Surgery

Interventions

Not provided

Countries

Belgium

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2019Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Nov 18, 2019

First Submission Date that Met QC Criteria

Nov 19, 2019

First Posted Date

Nov 20, 2019Actual

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

Nov 19, 2019

Last Update Posted Date

Nov 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

Detailed Description

Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

A note is made of the problem encountered, how long it took to place it correctly ( time from insertion till first staple), what was done to solve the problem, if a new identical tube was used or another and what type was used. If another tube how log did it take to get first stapler done.

some demographic and procedure information is recorded: gender, age, BMI, procedure planned, first bariatric procedure or second after ...

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
need to change gastric tube	rate of changing gastric tube	intraoperative
introduction time	time from start insertion till first staple in minutes	intraoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

bariatric surgery being sleeve gastrectomy, gastric bypass or conversion procedure.

Exclusion Criteria:

pre existing esophageal disease making use of gastric tube contra indicated, difficult or impossible.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient sheduled for bariatric surgery > 18 year sold and most of the time morbid obese. BMI > 35

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Paul Mulier	Contact	+3250452490		jan.mulier@azsintjan.be
jan Mulier	Contact

Overall Officials

Name	Affiliation	Role
Jan Paul Mulier	AZ Sint-Jan AV	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azsintjan		Bruges		8000	Belgium