Transparent Cap-Assisted Colonoscopy Combined With Computer-Aided Detection in Improving the Detection Rate of Colorectal Adenomas

NCT07097350 | Not Yet Recruiting

• 1 other identifier: 2025K239
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single-center, single-blind, randomized controlled study to compare the effectiveness of transparent cap-assisted colonoscopy combined with computer-aided detection and computer-aided detection alone in improvement of adenoma detection rate

Conditions

Colorectal Adenoma

Keywords

transparent cap; computer-aided detection; adenoma detection rate

Outcome Measures

Primary Outcomes (1)

• adenoma detection rate

  2 weeks after the procedure

Secondary Outcomes (6)

• sessile serrated lesion detection rate

  2 weeks after the procedure

• advanced adenoma detection rate

  2 weeks after the procedure

• polyp detection rate

  2 weeks after the procedure

• Clinically Significant Immediate Post-polypectomy Bleeding（CSIPB）rate

  immediately after the procedure

• Clinically Significant Delayed Post-polypectomy Bleeding（CSDPB）rate

  2 weeks after the procedure

Study Arms (2)

computer-aided detection alone

ACTIVE COMPARATOR

colonoscopy with computer-aided detection alone

Device: computer-aided detection alone

transparent cap-assisted colonoscopy combined with computer-aided detection

EXPERIMENTAL

transparent cap-assisted colonoscopy combined with computer-aided detection

Device: transparent cap-assisted colonoscopy combined with computer-aided detection

Interventions

computer-aided detection alone DEVICE

colonoscopy with computer-aided detection

computer-aided detection alone

transparent cap-assisted colonoscopy combined with computer-aided detection DEVICE

transparent cap-assisted colonoscopy combined with computer-aided detection

transparent cap-assisted colonoscopy combined with computer-aided detection

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 45-75 years

You may not qualify if:

• Patients scheduled for therapeutic colonoscopy as postoperative surveillance after colorectal surgery, post-polypectomy follow-up, or treatment of histologically confirmed polyps
• Patients with highly suspected or pathologically confirmed colorectal cancer
• Patients presenting with alarm symptoms or signs (hematochezia, melena, unexplained anemia or weight loss, palpable abdominal mass, or a positive digital rectal examination)
• Pregnant or breastfeeding women
• Patients with gastrointestinal obstruction
• Patients with inflammatory bowel disease, familial adenomatous polyposis, or serrated polyposis syndrome
• Patients who have taken anticoagulants (e.g., aspirin, warfarin) within 7 days before colonoscopy or who have coagulation disorders
• Patients currently enrolled in another clinical study or who participated in any clinical trial within the past 60 days
• Insertion failure for any reason (e.g., scope cannot pass an obstruction, patient cannot tolerate the procedure) or colonoscopy not reaching the cecum
• A Boston Bowel Preparation Scale (BBPS) score \< 6 at scope insertion (inadequate preparation requiring repeat bowel cleansing)
• Use of non-guideline-recommended bowel preparation agents
• Patients undergoing emergency colonoscopy

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

Study Officials

• Danian Ji, M.D.

  Huadong Hospital

  STUDY DIRECTOR

Central Study Contacts

Danian Ji, M.D.

CONTACT

+86-18019094606; arctg4@163.com

Zhiyu Dong, M.D.

CONTACT

+86-18817870866; 18817870866@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year after completion of this study
• Access Criteria: All researchers can require the original data from principal investigator of this study (Email address: arctg4@163.com)

Locations

CN (1)