Case Series With Saneso 360° Gastroscope

EGD Procedure Clinical Trial

Official title:

Case Series With Saneso 3600 Gastroscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621591
• Other study ID #: SAN360UGICL
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 9, 2020

Study information

• Verified date: November 2020
• Source: Saneso Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 9, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• EGD Procedure

Intervention

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

Locations

Country	Name	City	State
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	Glendale	West Virginia
United States	West Virginia University School of Medicine - Reynolds Memorial Hospital,	Glendale	West Virginia
United States	Valley Endoscopy Center	Saint Clairsville	Ohio
United States	West Virginia University School of Medicine - Wheeling Hospital	Wheeling	West Virginia
United States	Wintersville Endoscopy Center, Wintersville	Wintersville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Saneso Inc.	West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 24 hours on study day
Secondary	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).	Within 24 hours on study day
Secondary	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).	Within 7 days of completion of the study
Secondary	Evaluation of adverse events (AEs) related to the device.	AEs are assessed through 7 days after the procedure.	Within 7 days of completion of the study
Secondary	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).	Immediately after the use of the device