Comparison of computer-aided Detection (CADe), texture and Color Enhancement Imaging (TXI) and standard white light with narrow band imaging in Adenoma Detection during colonoscopy (ALIGN-ADR): A Prospective Randomized Controlled Study

Comparison of computer-aided Detection (CADe), texture and Color Enhancement Imaging (TXI) and standard white light with narrow band imaging (WLI+NBI) in Adenoma Detection during colonoscopy (ALIGN-ADR): A Prospective Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260314002

Enrollment

522

Registered

2026-03-14

Start date

2026-03-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal adenoma Colorectal cancer screening Colonic polyps Colonoscopy Adenoma Artificial intelligence Computer aided detection (CADe) Image enhanced endoscopy

Interventions

Colonoscopy performed using a computer aided detection (CADe) system providing real time artificial intelligence assisted polyp detection during withdrawal phase to improve adenoma detection.,Colonosc

Experimental Device,Experimental Device,Active Comparator Device

Computer aided detection assisted colonoscopy (CADe),Texture and color enhancement imaging colonoscopy (TXI),Standard white light imaging with narrow band imaging colonoscopy (WLI and NBI)

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 40 to 85 years 2. Patients undergoing screening colonoscopy 3. Patients undergoing diagnostic colonoscopy 4. Ability to provide written informed consent 5. Adequate bowel preparation allowing complete colonoscopic examination

Exclusion criteria

Exclusion criteria: 1. Known colorectal cancer 2. History of colorectal cancer treatment 3. Known hereditary colorectal cancer syndrome 4. Inflammatory bowel disease 5. Pregnancy or breastfeeding 6. Acute severe lower gastrointestinal bleeding 7. American Society of Anesthesiologists physical status classification of four or higher 8. Poor bowel preparation preventing adequate mucosal evaluation 9. Incomplete colonoscopy

Design outcomes

Primary

Measure	Time frame
Adenoma detection rate (ADR) At index colonoscopy Proportion of participants with at least one histologically confirmed adenoma detected during index colonoscopy (ADR)	—

Secondary

Measure	Time frame
PDR Day of index colonoscopy Proportion of participants with at least one polyp detected during index colonoscopy (PDR),APC Day of index colonoscopy Mean number of histologically confirmed adenomas per colonoscopy (APC),SSDR Day of index colonoscopy Proportion of participants with at least one histologically confirmed sessile serrated lesion detected during index colonoscopy (SSDR),Withdrawal time Day of index colonoscopy Mean withdrawal time in minutes from cecal intubation to rectal examination excluding therapeutic intervention time,Cecal intubation rate Day of index colonoscopy Proportion of colonoscopies reaching the cecum,Adverse events Day of index colonoscopy Proportion and type of adverse events related to colonoscopy ,Diagnostic performance Day of index colonoscopy Sensitivity and specificity of lesion classification compared with histopathology,ADR TXI1 vs TXI2 Day of index colonoscopy Proportion of participants with at least one histologically confirmed adenoma detected during colonoscopy comparing TXI Texture and Color Enhancement Imaging (TXI) mode 1 and TXI mode 2,CADe Performance EndoAims vs EndoBrain Day of index colonoscopy Sensitivity of computer-aided detection (CADe) system for detection of colorectal lesions confirmed by colonoscopy and histopathology using EndoAims compared with EndoBrain	—

Measure

Time frame

PDR Day of index colonoscopy Proportion of participants with at least one polyp detected during index colonoscopy (PDR),APC Day of index colonoscopy Mean number of histologically confirmed adenomas per colonoscopy (APC),SSDR Day of index colonoscopy Proportion of participants with at least one histologically confirmed sessile serrated lesion detected during index colonoscopy (SSDR),Withdrawal time Day of index colonoscopy Mean withdrawal time in minutes from cecal intubation to rectal examination excluding therapeutic intervention time,Cecal intubation rate Day of index colonoscopy Proportion of colonoscopies reaching the cecum,Adverse events Day of index colonoscopy Proportion and type of adverse events related to colonoscopy ,Diagnostic performance Day of index colonoscopy Sensitivity and specificity of lesion classification compared with histopathology,ADR TXI1 vs TXI2 Day of index colonoscopy Proportion of participants with at least one histologically confirmed adenoma detected during colonoscopy comparing TXI Texture and Color Enhancement Imaging (TXI) mode 1 and TXI mode 2,CADe Performance EndoAims vs EndoBrain Day of index colonoscopy Sensitivity of computer-aided detection (CADe) system for detection of colorectal lesions confirmed by colonoscopy and histopathology using EndoAims compared with EndoBrain

—

Countries

Thailand

Contacts

Public ContactThaksapron Jedsongtham

Department of Medicine, Faculty of Medicine, Prince of Songkla University

tsp.jed@gmail.com0802219995

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026