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

ConditionColorectal Adenoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorFudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 45-75 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: computer-aided detection aloneActive comparator 1 intervention
Group B: transparent cap-assisted colonoscopy combined with computer-aided detectionExperimental treatment 1 intervention

Trial outcomes

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

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

Time frame
immediately after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: