Validation of Aer-O-Scope Colonoscope System Cecal Intubation

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

Study Overview

• Status: Completed
• Conditions: Colonic Diseases; Colonic Polyp; Colon Cancer; Colonic Neoplasms; Colon Adenoma; Colon Disease; Colon Adenocarcinoma
• Intervention / Treatment: Device: Aer-O-Scope Colonoscopy

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 Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
2. Subject willing to undergo colon preparation bowel cleansing
3. 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).
4. Subject is able to understand and willing to sign informed consent form

Exclusion Criteria:

1. Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
2. 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)
3. Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
4. History of colonic resection
5. Clinically significant cardiovascular or pulmonary disease.
6. Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
7. Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
8. Pregnancy
9. Previous radiation therapy to the abdomen
10. Morbid Obesity (BMI > 40 kg/m2)
11. Drug abuse or alcoholism
12. Subject is bed-ridden and/or unable to adequately communicate
13. Subject is under custodial care
14. Subject has a history of psychiatric disorders which would prevent compliance with study instructions
15. Participation in a clinical study within the previous 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aer-O-Scope Validation of Cecal Intubation	The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope	30 minutes

Collaborators and Investigators

• Sponsor: GI View Ltd.
• Investigators: Principal Investigator: Nathan Gluck, MD, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): November 14, 2021

Study Registration Dates

• First Submitted: April 28, 2019
• First Submitted That Met QC Criteria: May 12, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: screening-colonoscopy; diagnostic-colonoscopy; surveillance-colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps; Colonic Neoplasms; Colonic Diseases
• Other Study ID Numbers: 1056CLD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual patient data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No