Clinical trial NCT04621591: Case Series With Saneso 360° Gastroscope
Official title: Case Series With Saneso 3600 Gastroscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: EGD Procedure
Lead sponsor: Saneso Inc.
Sponsor class: INDUSTRY
Collaborators: name: West Virginia University
First posted: 2020-11-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful EGD
timeFrame: Within 24 hours on study day
Secondary outcomes:
measure: Endoscopist qualitative rating of the Saneso 360° gastroscope
timeFrame: Within 24 hours on study day
measure: Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG)
timeFrame: Within 7 days of completion of the study
measure: Evaluation of adverse events (AEs) related to the device.
timeFrame: Within 7 days of completion of the study
measure: Evaluation of any potential mucosal injury
timeFrame: Immediately after the use of the device
Other outcomes:
Locations:
city: Saint Clairsville
country: United States
facility: Valley Endoscopy Center
state: Ohio
city: Wintersville
country: United States
facility: Wintersville Endoscopy Center, Wintersville
state: Ohio
city: Elkins
country: United States
facility: West Virginia University School of Medicine - Davis Medical Center
state: West Virginia
city: Glendale
country: United States
facility: West Virginia University School of Medicine - Reynolds Memorial Hospital
state: West Virginia
city: Glendale
country: United States
facility: West Virginia University School of Medicine - Reynolds Memorial Hospital,
state: West Virginia
city: Wheeling
country: United States
facility: West Virginia University School of Medicine - Wheeling Hospital
state: West Virginia
Study officials:
affiliation: West Virginia School of Medicine, Morgantown, WV
name: George Goetz, M.D; Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: