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Diagnosing small lesions in the colon using the WavSTAT device.

Differentiation of small colorectal lesions; laser-induced autofluorescence using the WavSTAT.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25180
Enrollment
205
Registered
2012-01-02
Start date
2011-03-24
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

differentiation, colonoscopy, white light, WavSTAT, optical diagnosis

Interventions

None listed

Sponsors

Academic Medical Centre, Amsterdam, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years; 2. Patients who are advised to undergo colonoscopic surveillance because of: A. A history of adenomatous polyps; B. Symptoms (e.g. change in bowel habits); C. Family history of CRC.

Exclusion criteria

Exclusion criteria: 1. Poor bowel preparation (scoring ≤ 4 points on the Boston Bowel Preparation Scale 8); 2. Polyposis syndromes; 3. History of inflammatory bowel disease; 4. Presence of conditions precluding histological sampling of the colon (e.g. coagulation disorders, anticoagulant therapy).

Design outcomes

Primary

MeasureTime frame
1. The overall accuracy of the WavSTAT represented by the sensitivity and specificity using final histopathology as golden standard; 2. The accuracy of the WavSTAT of lesions that are differentiated with white light endoscopy with low confidence, represented by the sensitivity and specificity using final histopathology as golden standard.

Secondary

MeasureTime frame
1. The percentage of lesions that is differentiated with white light endoscopy with high confidence; 2. The difference between trainees and expert endoscopists regarding the percentage of lesions that is differentiated with high confidence with white light endoscopy; 3. The accuracy for predicting histopathology in lesions that are differentiated with high confidence with white light endoscopy; 4. The difference in accuracy between trainees and expert endoscopists for predicting histopathology in lesions that are differentiated with high confidence with white light endoscopy.

Contacts

Public ContactEvelien Dekker

Academic Medical Center (AMC) Department of Gastroenterology and Hepatology P.O. Box 22660

e.dekker@amc.uva.nl+31 (0)20 5664702

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)