Prospective randomized trial to compare the clinical efficiency (Adenoma Detection Rate) of G-EYE(TM) HD Colonoscopy with Standard HD Colonoscopy

Completed

• Conditions: Adenoma coli; colonic polyps; 10017934; 10017987

• Registration Number: NL-OMON41850
• Lead Sponsor: SMART Medical Systems Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- Patiënts over 50 years old
- Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection)
- The patient must understand and provide written consent for the procedure

Exclusion Criteria

- Patients with inflammatory bowel disease, known polyposis syndrome, diverticulitis or toxic megacolon
- Patients with suspected chronic stricture potentially precluding complete colonoscopy
- Patients with a history of radiation therapy to abdomen or pelvis
- Pregnant or lactating female subjects
- Patients who are currently enrolled in another clinical investigation
- Patients with current oral or parenteral use of anticoagulants
- Patients with recent (within the last 3 months) coronary ischemia or CVA
- Previous colonic surgery (except for appendectomy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>G-EYE* colonoscopy detection rate of adenomas and serrated lesions compared to<br /><br>the standard colonoscopy detection rate of the same.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Polyp and adenoma detection, procedure times and safety.</p><br>