Case Series With Saneso 360° Gastroscope

Case Series With Saneso 3600 Gastroscope

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

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.

Inclusion Criteria:

• 18 -74 years of age
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
• Scheduled for a clinically indicated routine EGD procedure
• ASA class 1-3.

Exclusion Criteria:

• Altered esophageal, gastric, or duodenal anatomy
• Pregnant women, children under 18 years of age, and adults over 75 years of age.
• Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.
• Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
• ASA class 4-5.