Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Colon Cancer Clinical Trial

Official title:

Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949777
• Other study ID #: 1056CLD
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: November 14, 2021

Study information

• Verified date: August 2021
• Source: GI View Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 14, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenocarcinoma
• Colon Adenoma
• Colon Cancer
• Colon Disease
• Colonic Diseases
• Colonic Neoplasms
• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• Aer-O-Scope Colonoscopy
resection or biopsy of colonic abnormalities for histopathalogical evaluation

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
GI View Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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