colon cancer screening large bowel observation
Conditions
Interventions
None listed
Sponsors
PeerMedical Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subject between the ages of 18 and 70; • The patient is undergoing colonoscopy for colorectal cancer screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; • Written informed consent must be available before enrollment in the trial.
Exclusion criteria
Exclusion criteria: • Patients with a history of colonic resection. • Patients with known (or newly diagnosed) inflammatory bowel disease. • Patients with a personal history of polyposis syndrome. • Patients with suspected colonic stricture potentially precluding complete colonoscopy. • Patients with diverticulitis or toxic megacolon. • Patients with a history of radiation therapy to abdomen or pelvis. • Patients with acute lower GI-bleeding. • Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient*s participation in this study. • Pregnant women and women with childbearing potential without adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Standard view colonoscopy additional adenoma detection rate compared to the extended view additional adenoma detection rate using the PeerScope System*. • Standard view colonoscopy additional polyp detection rate compared to the extended view additional polyp detection rate using the PeerScope System*. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Performance of therapeutic interventions, such as biopsies, polypectomies, APC etc. • Procedure time. The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time. A stopwatch is needed for 4. with stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured • Sedation dosage. • Patient satisfaction. Patient's pain at the end of the procedure will be recorded using VAS scale. Results of 24 hour telephone follow-up to assess for post-procedural patient satisfactory will be recorded on the CRF. | — |
Countries
Netherlands
Outcome results
None listed