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| Name | Class |
|---|---|
| West Virginia University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saneso 360° gastroscope | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saneso 360° gastroscope | Device | Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Goetz, M.D; Ph.D. | West Virginia School of Medicine, Morgantown, WV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Endoscopy Center | Saint Clairsville | Ohio | 43950 | United States | ||
| Wintersville Endoscopy Center, Wintersville |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 3, 2022 | Aug 26, 2022 | 2 |
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| 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 |
| Wintersville |
| Ohio |
| 43953 |
| United States |
| West Virginia University School of Medicine - Davis Medical Center | Elkins | West Virginia | 26241 | United States |
| West Virginia University School of Medicine - Reynolds Memorial Hospital | Glendale | West Virginia | 26038 | United States |
| West Virginia University School of Medicine - Reynolds Memorial Hospital, | Glendale | West Virginia | 26506 | United States |
| West Virginia University School of Medicine - Wheeling Hospital | Wheeling | West Virginia | 26003 | United States |