I-Scan a Novel Endoscopic Tool for the Macroscopic Identification of Mucosal Lesions

NCT03298776 | Completed

• 1 other identifier: STH18011
• Study Type: interventional
• Target: 758
• Locations: 1 country
• Sites: 1

Brief Summary

The use of endoscopy for the diagnosis of gastrointestinal diseases has continued to increase in recent years. Endoscopy provides an advantage over other noninvasive or minimally invasive procedures in that it allows both direct visualisation of the mucosa but direct and accurate sampling of abnormalities for histological examination. However standard endoscopy does have some limitations particularly with small lesions and pan mucosal changes. Some lesions may be entirely benign and require no further intervention but as a result of difficulty with accurate endoscopic characterization of lesions in many cases unnecessary biopsies or polypectomies are undertaken. Therefore any technology that can augment the use of standard endoscopy to minimise unnecessary intervention should be encouraged. IScan is a digital enhancement technique available with Pentax endoscopes. There have been other novel endoscopic advances for example, Narrow band imaging but these have not been adopted widely for a number of reasons including technical difficulties or patient tolerability. The aim of this study is to assess whether Pentax IScan technology is a reliable method of improving our recognition of macroscopic mucosal lesions compared to standard white light endoscopy

Conditions

Endoscopy

Outcome Measures

Primary Outcomes (1)

• Clarity of mucosal lesions found using I-Scan

  The endoscopic assessment of mucosal lesions using standard endoscopy and standard endoscopy plus I-Scan Will be compared to histological assessment where this is indicated. Interobserver variability of assessment of mucosal lesions will be compared between endoscopic techniques

  through study completion, on average one year

Secondary Outcomes (1)

• Patient reported tolerability of I-scan procedure

  through study completion, on average one year

Study Arms (2)

standard white light endoscopy

ACTIVE COMPARATOR

Patients will undergo the standard of care which is standard white light endoscopy

Diagnostic Test: Standard endoscopy

Endoscopy and I-Scan

EXPERIMENTAL

Patients will undergo standard of care endoscopy plus the I-Scan

Device: I-Scan

Interventions

I-Scan DEVICE

I-Scan is a digital enhancement technique. These endoscopes already have greater definition compared to many standard endoscopes but they also utilise a 'zoom' function and digital image enhancement.

Endoscopy and I-Scan

Standard endoscopy DIAGNOSTIC_TEST

Patients referred for standard endoscopy to receive standard of care only

standard white light endoscopy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients attending for a routine diagnostic endoscopic procedure where Pentax endoscopes are in use at the endoscopy unit at the Royal Hallamshire Hospital.

You may not qualify if:

• Patients attending for a therapeutic endoscopic procedure.
• Patients with a known endoscopic diagnosis
• Patients with abnormal coagulation or any other contraindication to use of standard biopsy or polypectomy techniques used in routine diagnostic endoscopic procedures
• Patients who are unable to understand English or give informed consent
• Patients under the age of 16

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Study Officials

• David Sanders

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: October 2, 2017
• Study Start: September 26, 2013
• Primary Completion: August 6, 2018
• Study Completion: January 5, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)