Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2020-08-01
2020-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Saneso 360° gastroscope
Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.
Interventions
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Saneso 360° gastroscope
Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
74 Years
ALL
No
Sponsors
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West Virginia University
OTHER
Saneso Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George Goetz, M.D; Ph.D.
Role: PRINCIPAL_INVESTIGATOR
West Virginia School of Medicine, Morgantown, WV
Locations
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Valley Endoscopy Center
Saint Clairsville, Ohio, United States
Wintersville Endoscopy Center, Wintersville
Wintersville, Ohio, 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
West Virginia University School of Medicine - Wheeling Hospital
Wheeling, West Virginia, United States
Countries
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Other Identifiers
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SAN360UGICL
Identifier Type: -
Identifier Source: org_study_id