adenomata polyps
Conditions
Interventions
The Avantis Third Eye Retroscope auxiliary imaging system includes a catheter,
a cap and a video processor system.
The cap is placed on the tip of colonoscope prior to initiation of the
procedure. T
Sponsors
Avantis medical systems. Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup. 2. Age >= 18 years. 3. The patient must understand and provide written consent for the procedure.
Exclusion criteria
Exclusion criteria: 1. Age under 18. 2. Patients with a history of colonic resection. 3. Patients with inflammatory bowel disease. 4. Patients with a personal history of polyposis syndrome. 5. Patients with suspected chronic stricture potentially precluding complete colonoscopy. 6. Patients with diverticulitis or toxic megacolon. 7. Patients with a history of radiation therapy to abdomen or pelvis. 8. 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. 9. No written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Study the overall miss rate of polyps detected with the third eye retroscope compared to standard colonoscopy. 2. Study the overall miss rate of adenoma detected with the third eye retroscope compared to standard colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Study polyp characteristics, including the histological and pathological, of each for both groups. 2. Analyze the time observations, including time to cecum, time for withdrawal, the withdrawal time for both groups and total procedural times for each colonoscopy procedure. | — |
Countries
Netherlands
Outcome results
None listed