The MORDIS Study Clinical Investigational Plan

N/AUnknownNCT01980134

SpectraScience1,200 enrolled

Overview

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. * 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

Enrollment

1,200

Conditions

Adenoma

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Klinika Hepatogastroenterologie Ikem

Prague, Czech Republic, Czechia

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Universitäts Klinikum Tübingen

Tübingen, Germany

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

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.

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.

Central Contacts

Guido Costamagna, MD

CONTACT

+390630154083 gcostamagna@rm.unicatt.it

Data from ClinicalTrials.gov

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