EGD Procedure
Conditions
Brief summary
To confirm the procedural performance of the Saneso 360° gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures.
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.
Interventions
DEVICESaneso 360° gastroscope
Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.
Sponsors
West Virginia University
Saneso Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful EGD | 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
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist qualitative rating of the Saneso 360° gastroscope | 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) | 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. | Within 7 days of completion of the study | AEs are assessed through 7 days after the procedure. |
| Evaluation of any potential mucosal injury | 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). |
Countries
United States
Outcome results
None listed