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Clinical Trial Summary

To confirm the procedural performance of the Saneso 360° gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures.


Clinical Trial Description

This study is a prospective, multicenter case series per standard of care EGD procedures using a nonsignificant risk Saneso 360° gastroscope. 20 cases will be included at up to five (5) clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated EGD procedure performed using the study device. Immediately thereafter, patients will have an EGD procedure using a standard Gastroscope (Olympus GIF180) by a second endoscopist. Enrolled subjects will be followed for 7 days after their procedure. If the procedure is not successful with the study device, the endoscopist will complete the procedure with a traditional gastroscope used at each facility. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04621591
Study type Interventional
Source Saneso Inc.
Contact
Status Completed
Phase N/A
Start date August 1, 2020
Completion date September 9, 2020

See also
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