Case Series With Saneso 360° Gastroscope

Saneso Inc.22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

EGD Procedure

Interventions

Saneso 360° gastroscopeDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (6)

Valley Endoscopy Center

Saint Clairsville, Ohio, United States

Wintersville Endoscopy Center, Wintersville

Wintersville, Ohio, United States

West Virginia University School of Medicine - Davis Medical Center

Elkins, West Virginia, United States

West Virginia University School of Medicine - Reynolds Memorial Hospital

Outcomes

Primary Outcomes

Successful EGD

Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken.

Time frame: Within 24 hours on study day

Secondary Outcomes

Endoscopist qualitative rating of the Saneso 360° gastroscope

Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable).

Time frame: Within 24 hours on study day

Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG)

Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG).

Time frame: Within 7 days of completion of the study

Evaluation of adverse events (AEs) related to the device.

AEs are assessed through 7 days after the procedure.

Time frame: Within 7 days of completion of the study

Evaluation of any potential mucosal injury

Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear).

Time frame: Immediately after the use of the device

Data from ClinicalTrials.gov

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