The MORDIS Study Clinical Investigational Plan

Adenoma Clinical Trial

— MORDIS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01980134
• Other study ID #: MORDIS Study 010044-002
• Status: Recruiting
• Phase: N/A
• First received: November 1, 2013
• Last updated: April 12, 2016
• Start date: December 2013
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: SpectraScience
• Contact: Guido Costamagna, MD
• Phone: +390630154083
• Email: gcostamagna[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthCzech Republic: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and Female > 18 years

• Standard indication for colonoscopy OR CRC screening OR follow-up examination after the diagnosis of one or more established polyps OR polypectomy (analysis of polyps other than the intended polypectomy)

• Written informed consent

Exclusion Criteria:

• Inflammatory bowel disease

• Hereditary/genetic polyposis syndromes

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adenoma

Locations

Country	Name	City	State
Czech Republic	Klinika Hepatogastroenterologie Ikem	Praha
Denmark	Herlev Hospital	Herlev
Germany	Universitäts Klinikum Tübingen	Tübingen
Italy	European Institute of Oncology	Milan
Italy	Policlinico Universitario Gemeli	Roma
Sweden	SKANE University Hospital	Malmö

Sponsors (11)

Lead Sponsor

Collaborator

SpectraScience

Azienda Ospedaliera Universitaria Policlinico, Copenhagen University Hospital at Herlev, European Georges Pompidou Hospital, European Institute of Oncology, Innere Medizin I Interdisziplinäre Endoskopie Universitätsklinikum Tübingen, Institut des Maladies de l’Appareil digestif, Institute for Clinical and Experimental Medicine, Katholieke Universiteit Leuven, Skane University Hospital, University of Erlangen-Nürnberg

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Germany,  Italy,  Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	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.	No