Third Eye Retroscope Randomized Clinical Evaluatio

Completed

• Conditions: adenomata; polyps; 10017990; 10017991

• Registration Number: NL-OMON33766
• Lead Sponsor: Avantis medical systems. Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Study the overall miss rate of polyps detected with the third eye retroscope<br /><br>compared to standard colonoscopy.<br /><br>2. Study the overall miss rate of adenoma detected with the third eye<br /><br>retroscope compared to standard colonoscopy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Study polyp characteristics, including the histological and pathological, of<br /><br>each for both groups.<br /><br>2. Analyze the time observations, including time to cecum, time for withdrawal,<br /><br>the withdrawal time for both groups and total procedural times for each<br /><br>colonoscopy procedure.</p><br>