Case Series With Saneso 360° Gastroscop… | Clinical Trial

Key information

Conditions

EGD Procedure

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley Endoscopy Center, Saint Clairsville, Ohio, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saneso 360° gastroscope

Device

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

Primary outcomes

Successful EGD

Time frame: Within 24 hours on study day

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.

Secondary outcomes

Endoscopist qualitative rating of the Saneso 360° gastroscope

Time frame: Within 24 hours on study day

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

Time frame: Within 7 days of completion of the study

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

Time frame: Within 7 days of completion of the study

AEs are assessed through 7 days after the procedure.
Evaluation of any potential mucosal injury

Time frame: Immediately after the use of the device

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).

Sponsors and collaborators

Lead sponsor

Saneso Inc.

Industry

Collaborators

West Virginia University

Registry information

Official study title

Case Series With Saneso 3600 Gastroscope

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Nov 9, 2020
Registry last updated: Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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