Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training

NCT04838951 | Completed DMC

• 1 other identifier: 2021.141
• Study Type: interventional
• Target: 856
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists.

Conditions

Screening Colonoscopy

Outcome Measures

Primary Outcomes (1)

• ADR

  adenoma detection rate

  During the colonoscopy

Secondary Outcomes (13)

• ADR for adenomas of different sizes

  During the colonoscopy

• ADR for adenomas of different colonic segments

  During the colonoscopy

• Mean number of adenomas per colonoscopy

  During the colonoscopy

• Advanced adenoma detection rate

  During the colonoscopy

• Sessile serrate lesion (SSL) detection rate

  During the colonoscopy

Study Arms (2)

Intervention arm

EXPERIMENTAL

CADe system will be used during withdrawal phase of colonoscopy.

Device: ENDO-AID CADe

Control arm

NO INTERVENTION

Colonoscopy will be performed according to hospital protocol.

Interventions

ENDO-AID CADe DEVICE

ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Aged 18 years old or above;
• They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding;
• Written informed consent obtained.

You may not qualify if:

• Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
• Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets)
• Scheduled staged procedure for polypectomy or biopsy
• Previous colonic resection
• Personal history of colorectal cancer
• Personal history of polyposis syndrome
• Personal history of inflammatory bowel disease
• Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
• Pregnancy
• Unable to obtain informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Related Publications (1)

• Lau LHS, Ho JCL, Lai JCT, Ho AHY, Wu CWK, Lo VWH, Lai CMS, Scheppach MW, Sia F, Ho KHK, Xiao X, Yip TCF, Lam TYT, Kwok HYH, Chan HCH, Lui RN, Chan TT, Wong MTL, Ho MF, Ko RCW, Hon SF, Chu S, Futaba K, Ng SSM, Yip HC, Tang RSY, Wong VWS, Chan FKL, Chiu PWY; ENDOAID-TRAIN study group. Effect of Real-Time Computer-Aided Polyp Detection System (ENDO-AID) on Adenoma Detection in Endoscopists-in-Training: A Randomized Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):630-641.e4. doi: 10.1016/j.cgh.2023.10.019. Epub 2023 Nov 2.

  PMID: 37918685 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Specialist

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 9, 2021
• Study Start: April 19, 2021
• Primary Completion: July 22, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)