The MORDIS Study Clinical Investigational Plan (MORDIS)
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|ClinicalTrials.gov Identifier: NCT01980134|
Recruitment Status : Unknown
Verified April 2016 by SpectraScience.
Recruitment status was: Recruiting
First Posted : November 8, 2013
Last Update Posted : April 14, 2016
|Condition or disease|
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.
- Primary endpoint: To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions.
- Secondary Endpoint: 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.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Multicenter, Open, Prospective Study on Modified Resect and DIScard Strategy of Small Colonic Lesions Using WavSTAT4 Optical Biopsy System: The MORDIS Study Clinical Investigational Plan|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||November 2016|
- To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions. [ Time Frame: 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. ]The WavSTAT4 Optical Biopsy System result will be compared to physician visual diagnosis as well as the subsequent pathological report.
- Improved determination of post-polypectomy surveillance intervals [ Time Frame: 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. ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980134
|Contact: Guido Costamagna, MDfirstname.lastname@example.org|
|Klinika Hepatogastroenterologie Ikem||Recruiting|
|Praha, Czech Republic, Praha 4|
|Contact: MUDR. M. Benes, MD 420 26136 4016|
|Contact: Prof. Julius Spicak, MD 420 26136 4016|
|Herlev, Denmark, 2730|
|Contact: Peter Vilmann, MD 4991318545053 Peter.Vilmann@regionh.dk|
|Universitäts Klinikum Tübingen||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Martin Götz,, M.D. +49 7071 29 82162 email@example.com|
|Contact: Nisar Peter Malek, M.D. +49 7071 29 82162|
|European Institute of Oncology||Recruiting|
|Milan, Italy, 20141|
|Contact: Christiano Crosta, MD + 390257489067 firstname.lastname@example.org|
|Principal Investigator: Christiano Crosta, MD|
|Policlinico Universitario Gemeli||Not yet recruiting|
|Roma, Italy, 00168|
|Contact: Guido Costamagna, MD + 390630154083 email@example.com|
|Principal Investigator: Guido Costamagna, MD|
|SKANE University Hospital||Recruiting|
|Malmö, Sweden, SE-205 02|
|Contact: Ervin Toth, MD 46 40 33 1000/ 33 86 21 firstname.lastname@example.org|
|Principal Investigator:||Guido Costamagna, MD||Policlinico Gemeli, Roma, Italy|