The MORDIS Study Clinical Investigational Plan

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01980134

Acronym

MORDIS

Enrollment

1200

Registered

2013-11-08

Start date

2013-12-31

Completion date

2016-11-30

Last updated

2016-04-14

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

Conditions

Adenoma

Keywords

adenomatous colorectal lesions, colorectal polyps, polyps

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions.	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.

Secondary

Measure	Time frame	Description
Improved determination of post-polypectomy surveillance intervals	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.

Countries

Czechia, Denmark, Germany, Italy, Sweden

Contacts

Primary ContactGuido Costamagna, MD

gcostamagna@rm.unicatt.it+390630154083

Outcome results