Case Series With Saneso 3600 Colonoscope

Colonic Neoplasms Clinical Trial

Official title:

Case Series With Saneso 3600 Colonoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505370
• Other study ID #: SAN360LGICL
• Status: Completed
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Saneso Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Saneso colonoscope is a novel FDA cleared colonoscope that provides a 360 degree integrated view of the colon. Saneso colonoscope has five cameras and multiple LED lights at the distal head. The objective of the present study is to evaluate clinical success of the Saneso colonoscope in intubation of the terminal ileum and to obtain user feedback with regards to usability characteristics compared to predicate devices.

Description:

This study is a prospective, multi-center case series of per standard of care colonoscopy procedures using a nonsignificant risk Saneso 360 degree colonoscope. 40 cases were included at 3 clinical sites. Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist. Enrolled subjects were followed for 7 days after their procedure. If the procedure was not successful with the study device, the endoscopist completed the procedure with a traditional colonoscope used at each facility. This study was approved by the institutional review board of respective sites. The clinical trial was conducted in accordance with the standards of Good Clinical Practice (GCP) and in accordance with the principles of the Declaration of Helsinki.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 74 Years

Eligibility

Inclusion Criteria:

• 45 -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 colonoscopy procedure ASA class 1-3.

Exclusion Criteria:

• Altered colon 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.

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Device:
• Colonoscopy
Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist.

Locations

Country	Name	City	State
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	Valley Endoscopy Center	Saint Clairsville	Ohio
United States	Wintersville Endoscopy Center, Wintersville	Wintersville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Saneso Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation of terminal ileum and cecum	Intubation of the terminal ileum and cecum	4 months.
Secondary	User feedback for operating characteristics of the device	User feedback for operating characteristics of the device	4 months.