MedDataX Logo

Validation of Aer-O-Scope Colonoscope System Cecal Intubation

NCT ID: NCT03949777

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2021-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

screening-colonoscopy diagnostic-colonoscopy surveillance-colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Cohort

61 subjects will undergo colonoscopy

Group Type EXPERIMENTAL

Aer-O-Scope Colonoscopy

Intervention Type DEVICE

resection or biopsy of colonic abnormalities for histopathalogical evaluation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aer-O-Scope Colonoscopy

resection or biopsy of colonic abnormalities for histopathalogical evaluation

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

therapeutic intervention - polyp resection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GI View Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nathan Gluck, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1056CLD

Identifier Type: -

Identifier Source: org_study_id