Clinical trial NCT05505370: Case Series With Saneso 3600 Colonoscope
Official title: Case Series With Saneso 3600 Colonoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Keywords: Colonoscopy
Colonoscope
Lead sponsor: Saneso Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The objective of the present study is to Study the clinical success and clinical safety of the Saneso colonoscope
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intubation of terminal ileum and cecum
timeFrame: 4 months.
Secondary outcomes:
measure: User feedback for operating characteristics of the device
timeFrame: 4 months.
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
Study officials:
References: