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Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System

NCT05448300 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-07-12

No results posted yet for this study

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.

Conditions

  • Colon Adenoma
  • Colonoscopy

Interventions

DEVICE

Colonoscopy with water exchange or air insufflation methods

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.

Sponsors & Collaborators

  • Dalin Tzu Chi General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2023-05-15
Completion
2023-05-15
FDA Device
Yes

Countries

  • United States
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05448300 on ClinicalTrials.gov