Case Series With Saneso 360° Gastroscope

NCT04621591 | Completed DMC FDA Device

• 1 other identifier: SAN360UGICL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 6

Brief Summary

To confirm the procedural performance of the Saneso 360° gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures.

Conditions

EGD Procedure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Endoscopist qualitative rating of the Saneso 360° gastroscope

  Within 24 hours on study day

• 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

• Evaluation of adverse events (AEs) related to the device.

  Within 7 days of completion of the study

• Evaluation of any potential mucosal injury

  Immediately after the use of the device

Study Arms (1)

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.

Device: Saneso 360° gastroscope

Interventions

Saneso 360° gastroscope DEVICE

Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.

Saneso 360° gastroscope

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saneso Inc.: lead
• West Virginia University: collaborator

Study Sites (6)

Valley Endoscopy Center

Saint Clairsville, Ohio, 43950, United States

Location

Wintersville Endoscopy Center, Wintersville

Wintersville, Ohio, 43953, United States

Location

West Virginia University School of Medicine - Davis Medical Center

Elkins, West Virginia, 26241, United States

Location

West Virginia University School of Medicine - Reynolds Memorial Hospital

Glendale, West Virginia, 26038, United States

Location

West Virginia University School of Medicine - Reynolds Memorial Hospital,

Glendale, West Virginia, 26506, United States

Location

West Virginia University School of Medicine - Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

Study Officials

• George Goetz, M.D; Ph.D.

  West Virginia School of Medicine, Morgantown, WV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: August 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: September 9, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)