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.

Study Overview

• Status: Completed
• Conditions: EGD Procedure
• Intervention / Treatment: Device: Saneso 360° gastroscope

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Saint Clairsville, Ohio, United States, 43950
      • Valley Endoscopy Center
    • Wintersville, Ohio, United States, 43953
      • Wintersville Endoscopy Center, Wintersville
  • West Virginia
    • Elkins, West Virginia, United States, 26241
      • West Virginia University School of Medicine - Davis Medical Center
    • Glendale, West Virginia, United States, 26038
      • West Virginia University School of Medicine - Reynolds Memorial Hospital
    • Glendale, West Virginia, United States, 26506
      • West Virginia University School of Medicine - Reynolds Memorial Hospital,
    • Wheeling, West Virginia, United States, 26003
      • West Virginia University School of Medicine - Wheeling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Saneso 360° gastroscope; 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.	Device: Saneso 360° gastroscope; Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Saneso Inc.
• Collaborators: West Virginia University
• Investigators: Principal Investigator: George Goetz, M.D; Ph.D., West Virginia School of Medicine, Morgantown, WV

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SAN360UGICL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No