Recruiting

I-Scan vs. High Definition White Light

Sponsor:

University of Calgary

Code:

NCT02016326

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

HD Colon

I-scan 1

I-Scan 2

Study Details

Brief summary:

The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.

Primary Outcome:

Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.

Secondary Outcomes:

  • Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
  • Adenoma Detection Rate (ADR) in the right colon during the "Second look", irrespective of imaging modality.
  • Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.
  • Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.
  • Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.
  • Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.
  • Proportion of patients with diminutive lesions (< 5 mm) in each arm of the study
  • Proportion of patients with Flat lesions (height < 1/2 diameter) in each arm of the study
  • Proportion of patients with Sessile Serrated Adenoma in each arm of the study
  • Proportion of patients with invasive cancer in each arm of the study
  • Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.

Conditions

Colorectal Cancer

Study ID

NCT02016326

Start date

Nov, 2012

Status verified date

Dec, 2013

Completion date

Nov, 2014

Anticipated

Primary completion date

Nov, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All increased risk patients (Patients with family history or personal history of colon polyps or colon cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Screening Centre will be considered for enrollment.

Exclusion Criteria:

  • Average Risk patients
  • Previous colon surgery
  • Hereditary Polyposis Syndromes
  • Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium Enema, Virtual Colonoscopy, Flexible Sigmoidoscopy)

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: HD Colon

High Definition White Light modality will be used by the endoscopist for the entire procedure.

experimental: I-Scan 1

I-scan 1 modality will be used by the endoscopist for the entire procedure.

experimental: I-Scan 2

I-Scan 2 modality will be used by the endoscopist through out the procedure.

Interventions

HD Colon

High Definition White Light

I-scan 1

I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.

I-Scan 2

I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE)and Tone Enhancement(TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities. TE provides a uniform color image and is intended for detailed inspection of distinct lesions.

Primary outcome measure

  • Adenoma Detection Rate (ADR) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy. [ Time Frame: Colonoscopy report form provided to the Endoscopist will be filled out and collected after the procedure (1hour). All polyps reviewed by pathologist (1 week) ]

Central Contacts and Locations

Central contacts

Locations

Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Dec 19, 2013

Last verified

Dec, 2013

Keywords

  • Colonoscopy
  • High Definition White Light
  • I-Scan
  • Adenomas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2013-12-19.