Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Sponsor

GI View Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03949777

Collaborator

(none)

Enrollment

Location

Arm

22.3

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp Colonic Neoplasms Colonic Diseases Colon Adenoma Colon Disease Colon Adenocarcinoma Colon Cancer	Device: Aer-O-Scope Colonoscopy	N/A

Detailed Description

This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures.

Up to the first ten (10) cases for each physician will be system operation training cases.

The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Actual Study Start Date :

Jan 6, 2020

Actual Primary Completion Date :

Aug 10, 2021

Actual Study Completion Date :

Nov 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Cohort 61 subjects will undergo colonoscopy	Device: Aer-O-Scope Colonoscopy resection or biopsy of colonic abnormalities for histopathalogical evaluation Other Names: therapeutic intervention - polyp resection

Arm

Intervention/Treatment

Experimental: Study Cohort

61 subjects will undergo colonoscopy

Device: Aer-O-Scope Colonoscopy

resection or biopsy of colonic abnormalities for histopathalogical evaluation

Other Names:

therapeutic intervention - polyp resection

Outcome Measures

Primary Outcome Measures

Aer-O-Scope Validation of Cecal Intubation [30 minutes]
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
Subject willing to undergo colon preparation bowel cleansing
Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
Subject is able to understand and willing to sign informed consent form

Exclusion Criteria:

Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
History of colonic resection
Clinically significant cardiovascular or pulmonary disease.
Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
Pregnancy
Previous radiation therapy to the abdomen
Morbid Obesity (BMI > 40 kg/m2)
Drug abuse or alcoholism
Subject is bed-ridden and/or unable to adequately communicate
Subject is under custodial care
Subject has a history of psychiatric disorders which would prevent compliance with study instructions
Participation in a clinical study within the previous 30 days