NCT04621591

Case Series With Saneso 360° Gastroscope

Case Series With Saneso 3600 Gastroscope

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Saneso Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• EGD Procedure

Interventions

Type	Name	Description
DEVICE	Saneso 360° gastroscope	Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-08-30
• Completion: 2020-09-09
• First posted: 2020-11-09
• Last updated: 2020-11-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study