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| Name | Class |
|---|---|
| Azienda Ospedaliera Universitaria Policlinico | OTHER |
| European Institute of Oncology | OTHER |
| Institut des Maladies de l'Appareil digestif | UNKNOWN |
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To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even left in-situ) without adverse clinical impact.
To demonstrate the performance of the WavSTAT4 Optical Biopsy System when used at multiple centers.
Endpoint targets are based on the ASGE PIVI recommendations on real-time endoscopic assessment of the histology of diminutive colorectal polyps.
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| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions. | The WavSTAT4 Optical Biopsy System result will be compared to physician visual diagnosis as well as the subsequent pathological report. | WavSTAT4 Optical Biopsy System gives real-time result. Outcomes are measured when comparing the physician and WavSTAT4 system result to pathology results, which usually take one to two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Improved determination of post-polypectomy surveillance intervals | To show that use of the WavSTAT4 system used to determine histology of colorectal polyps ≤5 mm in size, when combined with the histo- pathologic assessment of polyps >5 mm in size, provides a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps. |
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Inclusion Criteria:
Exclusion Criteria:
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~1200 patients ≥ 18 years of age at the time of enrollment showing presence of diminutive colorectal polyps.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guido Costamagna, MD | Contact | +390630154083 | gcostamagna@rm.unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Guido Costamagna, MD | Policlinico Gemeli, Roma, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Hepatogastroenterologie Ikem | Recruiting | Prague | Czech Republic | Praha 4 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19910250 | Background | Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10. |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
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| European Georges Pompidou Hospital |
| OTHER |
| KU Leuven | OTHER |
| Innere Medizin I Interdisziplinäre Endoskopie Universitätsklinikum Tübingen | UNKNOWN |
| University of Erlangen-Nürnberg | OTHER |
| Copenhagen University Hospital at Herlev | OTHER |
| Skane University Hospital | OTHER |
| Institute for Clinical and Experimental Medicine | OTHER_GOV |
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Samples will be sent for pathological examination and potentially used for other research purposes.
| Outcome is measured when patients return for routine follow up. which is a long-term study as patients are not usually requested to return for another colonoscopy for many years. |
| Herlev Hospital | Recruiting | Herlev | 2730 | Denmark |
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| Universitäts Klinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
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| European Institute of Oncology | Recruiting | Milan | Italy | 20141 | Italy |
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| Policlinico Universitario Gemeli | Not yet recruiting | Roma | Italy | 00168 | Italy |
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| SKANE University Hospital | Recruiting | Malmö | SE-205 02 | Sweden |
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| D013568 | Pathological Conditions, Signs and Symptoms |