NCT04670718

Brief Summary

This is a pilot study aiming to investigate the ability of a novel Optical Coherence Tomography (OCT) probe in assessing the different layers of the gastrointestinal tract and the depth of invasion of early neoplasia, utilising surgically and endoscopically resected specimens

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

December 11, 2020

Last Update Submit

July 27, 2021

Conditions

Gastrointestinal Neoplasms

Keywords

Gastrointestinal neoplasmOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Visualisation of gastrointestinal tract

    Visualisation of different layers of gastrointestinal tract. Ability to differentiate mucosa and submucosa and muscular propria layer. (Yes or No).

    1 day

Secondary Outcomes (1)

  • Ability to asses depth of invasion of resected GI early tumor

    1 day

Study Arms (1)

OCT probe

EXPERIMENTAL

The examination of gastrointestinal tract resected specimen with the use of the OCT probe

Device: Optical Coherence Tomography Probe

Interventions

Optical Coherence Tomography ProbeDEVICE

Use of OCT probe for examination of gastrointestinal tract

OCT probe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with esophageal, gastric or colonic cancer undergoing elective surgical resection
  • Patients with early esophageal, gastric or colonic neoplasia undergoing endoscopic resection (Endoscopic submucosal dissection)

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Hon Chi Yip, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 17, 2020

Study Start

December 10, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

HK(1)