CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
ViSiGi® 3D suction calibration device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03939819
NCT03939819N/ACompleted
CompareCT.gov

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

Emory University·interventional·Posted May 7, 2019·Updated May 21, 2024

In Brief

A clinical study evaluating ViSiGi® 3D suction calibration device and Esophagogastroduodenoscopy (EGD) calibration for Gastrectomy and Obesity. Completed, enrolled 106 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrectomy, Obesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 7, 2019
Enrollment StartJul 30, 2019
Primary CompletionFeb 1, 2022
Study CompletionFeb 2, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.2 years ago

Interventions

ViSiGi® 3D suction calibration devicedevice

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) calibrationdevice

Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.