Clinical trial · Interventional
Artificial Intelligence in Colonoscopy
A Randomized Trial on the Utilization of Endocuff-assisted Colonoscopy and Computer-aided Detection in Optimizing Colonoscopies in the Elderly
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
N = 264 patients (50% female) aged 75 years and above undergoing colonoscopy were enrolled. Patients were randomly assigned into one of the three intervention groups: the primary intervention arm (CADe in combination with the MED), the second group with MED alone, and the control group with WLE. All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was the adenoma detection rate. Secondary outcomes were adenoma detection in the left colon in our cohort of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial Intelligence | Device | — | UNRESOLVED |
| Mucosal Exposure Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Primary Intervention Arm
- description
- In this arm, colonoscopy was performed using Computer Aided detection in combination with a Mucosal Exposure Device, which is FDA approved.
- interventionNames
- Device: Artificial Intelligence
- Device: Mucosal Exposure Device
- type
- EXPERIMENTAL
- label
- Secondary Intervention Arm
- description
- In this arm, participants underwent colonoscopy solely with an FDA approved Mucosal Exposure Device
- interventionNames
- Device: Mucosal Exposure Device
- type
- NO_INTERVENTION
- label
- Control group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria 1. Patients aged 75 years and older. 2. Patients who were able to provide informed consent or had a legally authorized representative who can consent on their behalf. 3. Patients who were deemed fit for colonoscopy based on a pre-procedure evaluation. Exclusion criteria 1. Patients with acute gastrointestinal conditions such as active colitis, acute diverticulitis, or bowel obstruction. 2. Patients with a history of major colorectal surgery that might alter normal colon anatomy (e.g., colectomy). 3. Patients with severe comorbid conditions that would contraindicate colonoscopy, such as severe cardiopulmonary disease or advanced liver disease. 4. Patients with uncorrected coagulopathies or those on anticoagulation therapy that cannot be safely managed around the time of the procedure. 5. Patients who are unable to adequately prepare the bowel for colonoscopy. 6. Patients who refuse to participate in the study or have a legally authorized representative who refuses consent.
References
Publications (2)
- BACKGROUNDPohl H, Robertson DJ. Colorectal cancers detected after colonoscopy frequently result from missed lesions. Clin Gastroenterol Hepatol. 2010 Oct;8(10):858-64. doi: 10.1016/j.cgh.2010.06.028. Epub 2010 Jul 22. PMID 20655393
- BACKGROUNDDekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0. PMID 31631858