Colonic Polyp
Conditions
Brief summary
The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients. Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.
Interventions
DEVICEEFOV Colonoscope
Routine colonoscopy using the EFOV lens in the colonoscope.
Sponsors
Pentax Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Screening for colorectal cancer at the age greater than or equal to 50 years, or evaluation of a positive stool test (i-FOBT) or polyp surveillance. * Signed informed consent.
Exclusion criteria
* ASA classification ≥3. * Age \<18 years. * Known or suspicion of inflammatory bowel disease. * Known polyp(s) for polypectomy. * High risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease. * Prior colorectal surgery. * Vulnerable subjects or subjects unable to follow the procedures of the investigation, e.g., due to language problems. * Unable or unwilling to undergo bowel cleansing for colonoscopy. * Female patients who are pregnant or nursing. * Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cecal Intubation Rate | Day 1 | The proportion of procedures in which the cecum was reached. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ileum Intubation Rate | Day 1 | Success rate of reaching the Ileum. |
| Therapeutic Intervention Success Rate | Day 1 | The ability to collect a biopsy or remove a polyp. |
| Mean number of polyps per coloscopy and its detection rate | Day 1 | Count of number of polyps seen during colonoscopy |
| Procedure Time | Day 1 | Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time. |
| Mean number of sessile serrate lesions and its detection rate | Day 14 | Count of number of adenomas/sessile serrate lesions defined by pathology |
| Patient Satisfaction Survey | Day 14 | During a follow-up phone call, the patient will be asked a yes or no question to rate their satisfaction of the procedure. |
| Mean number of adenomas and its detection rate | Day 14 | Count of number of adenomas/sessile serrate lesions defined by pathology |
Countries
Germany
Outcome results
None listed