Validation of Aer-O-Scope Colonoscope System Cecal Intubation

NCT03949777 | Completed

• 1 other identifier: 1056CLD
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonic Polyp; Colonic Neoplasms; Colonic Diseases; Colon Adenoma; Colon Disease; Colon Adenocarcinoma; Colon Cancer

Keywords

screening-colonoscopy; diagnostic-colonoscopy; surveillance-colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Cohort

EXPERIMENTAL

61 subjects will undergo colonoscopy

Device: Aer-O-Scope Colonoscopy

Interventions

Aer-O-Scope Colonoscopy DEVICE

resection or biopsy of colonic abnormalities for histopathalogical evaluation

Also known as: therapeutic intervention - polyp resection

Study Cohort

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GI View Ltd.: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms; Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Nathan Gluck, MD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 28, 2019
• First Posted: May 14, 2019
• Study Start: January 6, 2020
• Primary Completion: August 10, 2021
• Study Completion: November 14, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)