Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy
NCT ID: NCT03939819
Last Updated: 2024-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2019-07-30
2022-02-02
Brief Summary
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Detailed Description
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During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ViSiGi® 3D suction calibration device
The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing.
ViSiGi® 3D suction calibration device
ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
Esophagogastroduodenoscopy (EGD) calibration
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
Esophagogastroduodenoscopy (EGD) calibration
Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
Interventions
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ViSiGi® 3D suction calibration device
ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
Esophagogastroduodenoscopy (EGD) calibration
Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
Eligibility Criteria
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Inclusion Criteria
* agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice
Exclusion Criteria
* Concomitant hiatal surgery
* Paraesophageal hernia at time of surgery
* Any subject with prescribed immunosuppressive drugs.
* In the opinion of investigator, subject is not eligible to participate in the study.
* If patient is a female and becomes pregnant at any time during the study duration
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Elizabeth Hechenbleikner
Principal Investigator
Principal Investigators
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Elizabeth Hechenbleikner, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00108907
Identifier Type: -
Identifier Source: org_study_id
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