MedDRA - Lynch-Syndrome
Conditions
Interventions
Group 1: standard high definition white light endoscopy (HD-WLE)
Group 2: standard high definition white light endoscopy (HD-WLE) with additional use of CAD EYE
Sponsors
Medizinische Klinik und Poliklinik I Abteilung Innere Medizin I Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General inclusion criteria: • Age =18 years • Written informed consent of the subject for voluntary participation in the study. • Subjects with the ability to follow study instructions and likely to attend and complete all required visits Indication-specific inclusion criteria: • Proven presence of a pathogenic germline variant in MLH1, MHS2 or MSH6 (Lynch Syndrome) • Interval to last colonoscopy 10-36 months
Exclusion criteria
Exclusion criteria: General exclusion criteria: • Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this study • Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical study or may prevent sufficient compliance • Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning • Screening laboratory test results within the following parameters (if 1 or more of the laboratory parameters is out of range, a single retest of laboratory values is permitted during the approximately 4-week screening period): o Quick >50%, o Thrombocytes >50.000 G/l Exclusion criteria regarding special restrictions for females: • Current or planned pregnancy or nursing women • Negative pregnancy test in women with child-bearing potential Indication specific exclusion criteria: • Previous extensive colorectal surgery (proctocolectomy or colectomy with ileorectal anastomosis) • Index colonoscopy Insufficient bowel preparation (Boston score of <2 by colonic segment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimation of the adenoma detection rate (ADR) using automated real-time detection (CADEYE) or white light endoscopy (WLE). | — |
Secondary
| Measure | Time frame |
|---|---|
| • detection rate of sessile serrated lesions • total number and size of detected adenomas • total number and size of sessile serrated lesions • examination time • occurence of (serious) adverse events | — |
Countries
Germany
Contacts
Public ContactRobert Hüneburg
Medizinische Klinik und Poliklinik I Abteilung Innere Medizin I Universitätsklinikum Bonn
Outcome results
None listed