NCT05448300

Brief Summary

Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. A modified Delphi review reported water exchange showed the highest overall ADR, ADR in screening cases, and in the right side of the colon compared with water immersion and air (or CO2) insufflation. One of the plausible mechanisms of improving ADR by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. However, no RCT has been performed to evaluate the effect of CADe on WE colonoscopy. Therefore, investigators will conduct a RCT comparing the ADR of CADe assisted colonoscopy inserted with either WE or insufflation. Our hypothesis will be that CADe assisted WE colonoscopy achieves higher ADR than CADe assisted air insufflation colonoscopy.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
2 countries

2 active sites

Status
unknown

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

May 16, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

June 21, 2022

Last Update Submit

July 8, 2022

Conditions

Colon AdenomaColonoscopy

Keywords

adenoma detection rate, computer-aided system

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate

    proportion of patients with at least one colorectal adenoma detected among all patients examined by an endoscopist

    During each colonoscopy procedure

Secondary Outcomes (1)

  • false positive rate

    During each colonoscopy procedure

Study Arms (2)

Water exchange

ACTIVE COMPARATOR

This group of participants receives water exchange colonoscopy with the computer-aided polyp detection system.

Device: Colonoscopy with water exchange or air insufflation methods

Air insufflation

ACTIVE COMPARATOR

This group of participants receives air insufflation colonoscopy the computer-aided polyp detection system.

Device: Colonoscopy with water exchange or air insufflation methods

Interventions

Colonoscopy with water exchange or air insufflation methodsDEVICE

Using computer-aided polyp detection algorithm on colonoscopy with water exchange or air insufflation methods. This computer-aided algorithm does not intervene directly the colonoscopy procedure.

Air insufflationWater exchange

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients, undergoing screen, diagnostic or surveillance colonoscopy performed by the participating endoscopists will be enrolled.

You may not qualify if:

  • We excluded patients age \< 50 or \> 80 years old, undergone colonoscopy in the past 3 years, partial intake of bowel preparation, renal failure, previous colonic resection, scheduled for polypectomy, American Society of Anesthesiology (ASA) Risk Class 3 or higher, and lack of written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sepulveda Ambulatory Care Center

Los Angeles, California, 91343, United States

ACTIVE NOT RECRUITING

Chia Pei Tang

Chiayi City, Chiayi County, 62247, Taiwan

RECRUITING

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Chia Pei Tang, MD

CONTACT

0921128335franktg@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In two groups with blinding
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of endoscopy room

Study Record Dates

First Submitted

June 21, 2022

First Posted

July 7, 2022

Study Start

May 16, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

US(1)TW(1)