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NCT Number: NCT07097350

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

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

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Key information

Conditions

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • Patients are undergone screening or surveillance colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
  • 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.
  • Collecting variables which consist of primary and secodary outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

computer-aided detection alone

Device

colonoscopy with computer-aided detection

transparent cap-assisted colonoscopy combined with computer-aided detection

Device

transparent cap-assisted colonoscopy combined with computer-aided detection

Primary outcomes

  1. adenoma detection rate

    Time frame: 2 weeks after the procedure

Secondary outcomes

  1. sessile serrated lesion detection rate

    Time frame: 2 weeks after the procedure

  2. advanced adenoma detection rate

    Time frame: 2 weeks after the procedure

  3. polyp detection rate

    Time frame: 2 weeks after the procedure

  4. Clinically Significant Immediate Post-polypectomy Bleeding(CSIPB)rate

    Time frame: immediately after the procedure

    CSIPB was defined as any bleeding not responding to water jet irrigation or STSC and therefore requiring either coagu lation forceps or mechanical clips to achieve hemostasis

  5. Clinically Significant Delayed Post-polypectomy Bleeding(CSDPB)rate

    Time frame: 2 weeks after the procedure

    CSPEB was defined as any bleeding after completion of the procedure requiring emergency room presentation, hospital isation or re-intervention (endoscopy, angiography, surgery).

  6. perforation rate

    Time frame: immediately after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Danian Ji, M.D.

CONTACT

[email protected]

+86-18019094606

Zhiyu Dong, M.D.

CONTACT

[email protected]

+86-18817870866

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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