Performance Study of the Invendo C20 Colonoscope System in Colorectal Cancer Screening

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

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-12-31

Brief Summary

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

The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Study on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies

NCT05869838

Colonic Polyp

RECRUITING

Blood and Tissue Sample Collection for Future Colon Cancer Biomarker Studies in Patients Undergoing Colonoscopy

NCT00897403

Colorectal Cancer Health Status Unknown

COMPLETED

Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening

NCT02738359

Colon Cancer Rectum Cancer

RECRUITING

CT Colonography as the Initial Diagnostic Imaging Tool for Patients With Suspected Colorectal Cancer

NCT02820389

Colorectal Cancer

UNKNOWN

Screening for Colorectal Neoplasm in First Degree Relatives of the Affected

NCT00164944

Colorectal Cancer Screening

COMPLETED

Detailed Description

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

Conditions

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

Colorectal Cancer Screening

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

U.S. CRC screening population

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

1. Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
2. Age between 50-75 years
3. Signed informed consent

Exclusion Criteria

1. Family or personal history of colorectal neoplasia including familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer
2. Prior colonoscopy within preceding 10 years
3. A suspected diagnosis of inflammatory bowel disease, bowel obstruction, acute diverticulitis, known severe diverticulosis or any known large bowel disease
4. Clinically significant cardiovascular or pulmonary diseases
5. Gastrointestinal-tract related symptoms, complaints or diseases suggesting performance of colonoscopy (no screening cases)
6. Cancer or other life threatening diseases or significant chronic conditions
7. Blood clotting disorders and /or anti-coagulant therapy including aspirin within the last 7 days
8. Known pregnancy or positive screening pregnancy tests
9. Previous abdominal surgery except for uncomplicated cholecystectomy, appendectomy or minor pelvic surgery (e.g. hernia repair, oophorectomy)
10. Morbid obesity (BMI \> 40)
11. Clinically significant abnormal screening laboratory findings
12. Clinically significant abnormal screening ECG findings
13. Drug abuse or alcoholism
14. Inability of the screenee to adequately communicate
15. Screenees under custodial care
16. Participation in a clinical study within the last 30 days

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes