Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Not Applicable

Completed

• Conditions: Colonic Polyp; Colonic Neoplasms; Colon Adenocarcinoma; Colon Adenoma; Colon Disease; Colonic Diseases; Colon Cancer
• Interventions: Device: Aer-O-Scope Colonoscopy

• Registration Number: NCT03949777
• Lead Sponsor: GI View Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-04-28
• Study First Submitted QC: 2019-05-12
• Study First Posted: 2019-05-14
• Study Start: 2020-01-06
• Status Verified: 2021-08
• Primary Completion: 2021-08-10
• Study Completion: 2021-11-14
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Cohort	Aer-O-Scope Colonoscopy	61 subjects will undergo colonoscopy

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel