Case Series With Saneso 3600 Colonoscope

NCT05505370 | Completed DMC FDA Device

• 1 other identifier: SAN360LGICL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Colonic Neoplasms

Keywords

Colonoscopy; Colonoscope

Outcome Measures

Primary Outcomes (1)

• Intubation of terminal ileum and cecum

  Intubation of the terminal ileum and cecum

  4 months.

Secondary Outcomes (1)

• User feedback for operating characteristics of the device

  4 months.

Study Arms (2)

Study Arm Study device

EXPERIMENTAL

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.

Device: Colonoscopy

Study Arm - Predicate Device

ACTIVE COMPARATOR

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.

Device: Colonoscopy

Interventions

Colonoscopy DEVICE

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.

Study Arm - Predicate Device; Study Arm Study device

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 colonoscopy procedure ASA class 1-3.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saneso Inc.: lead

Study Sites (5)

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

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

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

Model Details: The objective of the present study is to Study the clinical success and clinical safety of the Saneso colonoscope

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 17, 2022
• Study Start: April 21, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 31, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

US (5)