An interventional study of Saneso 360° gastroscope in EGD Procedure, sponsored by Saneso Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Saneso Inc. · Not applicable, Interventional, and Other
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.
Saneso Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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
Plan to share: No
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Saneso Inc.