I-Scan Versus High-definition White Light

NCT01617278 | Completed

• 1 other identifier: 23474-P
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the 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: To estimate the mean number of adenomas per colonoscopy for both high definition white light colonoscopy and I-scan enhanced colonoscopy Secondary Outcomes:

1. 1.To estimate the recruitment rate
2. 2.Number of adenomas detected in the right colon during the second look

Conditions

Colorectal Cancer

Keywords

Colonoscopy; I Scan; High definition white light; Adenomas

Outcome Measures

Primary Outcomes (1)

• Mean number of adenomas per colonoscopy

  The "Colonoscopy Report Form" completed by the Physician helps to assess the number of polyps and a endoscopic description (location, size, shape) of these lesions including. Following formal review by the pathologist the polyp classification (e.g. whether it is an adenoma) is determined.

  Colonoscopy report form provided to the physician will be filled out and collected after the procedure (1 hour). All polyps reviewed by pathologist (1 week).

Secondary Outcomes (2)

• Number of adenomas detected in the right colon during the second look

  Second look in the right colon and finally withdrawing through the entire colon (approximately 5 min)

• To estimate the recruitment rate

  Upto 8 months

Study Arms (3)

I-Scan 1

EXPERIMENTAL

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

Device: I-Scan 1

HD Colon

EXPERIMENTAL

High definition white light modality will be used by the endoscopist for the entire procedure

Device: HD Colon

I-scan 2

EXPERIMENTAL

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

Device: I-Scan 2

Interventions

I-Scan 1 DEVICE

I-Scan 1 has contrast enhancement (CE)and 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 1

HD Colon DEVICE

High definition white light

HD Colon

I-Scan 2 DEVICE

I-Scan 2 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 colour image and is intended for detailed inspection of distinct lesions.

I-scan 2

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Centre will be considered for enrollment

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Forzani & MacPhail Colon Cancer Screening Centre, Alberta Health Services

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Robert Hilsden, MD

  Faculty of Medicine, University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine & Research Director, Colon Cancer screening Centre

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 12, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 4, 2013

Record last verified: 2013-07

Locations

CA (1)