Clinical trial · Interventional
Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
NCT05470452CI-TRIAL-00059831unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed by Wuhan ENDOANGEL Medical Technology Co., Ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. The aim of this study is to evaluate the safety and effectiveness of the software in clinical use.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No ENDOANGEL assistance during the reading process | Other | — | UNRESOLVED |
| The reading process is assisted by ENDOANGEL | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Physician AI-assisted diagnosis group
- interventionNames
- Other: The reading process is assisted by ENDOANGEL
- type
- SHAM_COMPARATOR
- label
- Physician Independent Diagnostic Group
- interventionNames
- Other: No ENDOANGEL assistance during the reading process
Primary outcomes (1)
- measure
- AFROC-AUC
- timeFrame
- 3 months
- description
- AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18, male or female； 2. Cases with complete, clear imaging data, including images under white light and magnified stained images； 3. Complete pathological diagnosis of upper digestive tract lesions; 4. The included cases were excluded from the software development. Exclusion Criteria: 1. Cases whose image data did not meet the evaluation requirements; 2. The investigator considered the case unsuitable for the clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.