Case Series With Saneso 360° Gastroscope

Saneso

Status: Completed

Conditions: EGD Procedure

Treatments: Device: Saneso 360° gastroscope

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04621591

SAN360UGICL

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

Saneso 360° gastroscope

Experimental group

Description:

Subjects will have a clinically indicated per standard of care EGD procedure performed using the Saneso 360° gastroscope. Immediately thereafter Patients will then have an EGD procedure using a standard Gastroscope (Olympus GIF 180) performed by a second endoscopist.

Treatment:

Device: Saneso 360° gastroscope