Evaluating the Clinical Value of Transparent Cap-Assisted Second Examination of the Sigmoid Colon for Improving Colorectal Adenoma Detection Rates

NCT07261319 | Not Yet Recruiting

• 1 other identifier: 2025K351
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single-center, single-blind, randomized controlled study to evaluate the clinical value of transparent cap-assisted second examination of the sigmoid colon for improving colorectal adenoma detection rates

Conditions

Colorectal Adenoma

Keywords

transparent cap; adenoma detection rate; second examination; sigmoid colon

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate in the rectum and sigmoid colon

  2 weeks after the procedure

Secondary Outcomes (12)

• Increased adenoma detection rate in the rectum and sigmoid colon achieved by second examination

  2 weeks after the procedure

• Adenoma miss rate in the rectum and sigmoid colon

  2 weeks after the procedure

• Per-colonoscopy adenoma miss rate in the rectum and sigmoid colon

  2 weeks after the procedure

• Sessile serrated lesion detection rate in rectum and sigmoid colon

  2 weeks after the procedure

• Advanced adenoma detection rate in rectum and sigmoid colon

  2 weeks after the procedure

Study Arms (2)

Standard second examination of the sigmoid colon

ACTIVE COMPARATOR

Standard second examination of the sigmoid colon

Device: standard second examination of the sigmoid colon

transparent cap-assisted second examination of the sigmoid colon

EXPERIMENTAL

transparent cap-assisted second examination of the sigmoid colon

Device: transparent cap-assisted second examination of the sigmoid colon

Interventions

transparent cap-assisted second examination of the sigmoid colon DEVICE

transparent cap-assisted second examination of the sigmoid colon

transparent cap-assisted second examination of the sigmoid colon

standard second examination of the sigmoid colon DEVICE

standard second examination of the sigmoid colon

Standard second examination of the sigmoid colon

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
• Inadequate withdrawal time (defined as a withdrawal time \<6 minutes during the first examination or \<2 minutes during the second examination)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

Study Officials

• Danian Ji

  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: November 22, 2025
• First Posted: December 3, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

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)