NCT03939819

Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

Comparison Between Endoscopic vs. Suction Calibration System on Number of Staple Load Firings, Operative Duration, Cost, and Gastro-esophageal Reflux Disease Following Laparoscopic Sleeve Gastrectomy: is There a Difference

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 "laparoscopic sleeve gastrectomy" (LSG).

Detailed description

There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus. 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

• Gastrectomy
• Obesity

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Esophagogastroduodenoscopy (EGD) calibration	Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.

Timeline

• Start date: 2019-07-30
• Primary completion: 2022-02-01
• Completion: 2022-02-02
• First posted: 2019-05-07
• Last updated: 2024-05-21
• Results posted: 2023-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study