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

NCT ID: NCT07097350

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-08-01

Brief Summary

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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

Detailed Description

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1. Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
2. Randomize into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: computer-aided detection alone and (2) Group 2: transparent cap-assisted computer-aided detection.
3. Collecting variables which consist of primary and secodary outcomes.

Conditions

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Colorectal Adenoma

Keywords

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transparent cap computer-aided detection adenoma detection rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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computer-aided detection alone

colonoscopy with computer-aided detection alone

Group Type ACTIVE_COMPARATOR

computer-aided detection alone

Intervention Type DEVICE

colonoscopy with computer-aided detection

transparent cap-assisted colonoscopy combined with computer-aided detection

transparent cap-assisted colonoscopy combined with computer-aided detection

Group Type EXPERIMENTAL

transparent cap-assisted colonoscopy combined with computer-aided detection

Intervention Type DEVICE

transparent cap-assisted colonoscopy combined with computer-aided detection

Interventions

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computer-aided detection alone

colonoscopy with computer-aided detection

Intervention Type DEVICE

transparent cap-assisted colonoscopy combined with computer-aided detection

transparent cap-assisted colonoscopy combined with computer-aided detection

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aged 45-75 years

Exclusion Criteria

* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhijun Bao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danian Ji, M.D.

Role: STUDY_DIRECTOR

Huadong Hospital

Locations

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Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Danian Ji, M.D.

Role: CONTACT

Phone: +86-18019094606

Email: [email protected]

Zhiyu Dong, M.D.

Role: CONTACT

Phone: +86-18817870866

Email: [email protected]

Facility Contacts

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Danian Ji, M.D.

Role: primary

Zhiyu Dong, M.D.

Role: backup

Other Identifiers

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2025K239

Identifier Type: -

Identifier Source: org_study_id