Evidence map›Paper›PMID 42393687›Full record

Trial reportBiomedical engineering online2026

Technical and clinical feasibility of single-use gastroscopy with real-time AI-based quality monitoring and single-use colonoscopy: a prospective two-center study.

Yang Lv, Long Xu, Wei Gong, Ying Zhu, Wen Xu, Guili Xia, Zhili Zhang, Fachao Zhi

Abstract readClinical TrialMulticenter StudyObservational Study
In one paragraph

Trial report in Biomedical engineering online, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yang LvDepartment of Gastroenterology, Guangdong Provincial Key Laboratory of Gastroenterology, Institute of Gastroenterology of Guangdong Province, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue North, Guangzhou, 510515, Guangdong, China.
Long XuDepartment of Gastroenterology, Shenzhen University General Hospital, Shenzhen, 518055, Guangdong, China.
Wei GongDepartment of Gastroenterology, Shenzhen Hospital of Southern Medical University, Shenzhen, 518000, Guangdong, China.
Ying ZhuDepartment of Gastroenterology, Shenzhen Hospital of Southern Medical University, Shenzhen, 518000, Guangdong, China.
Wen XuDepartment of Gastroenterology, Shenzhen Hospital of Southern Medical University, Shenzhen, 518000, Guangdong, China.
Guili XiaDepartment of Gastroenterology, Shenzhen Hospital of Southern Medical University, Shenzhen, 518000, Guangdong, China.
Zhili ZhangDepartment of Gastroenterology, Shenzhen University General Hospital, Shenzhen, 518055, Guangdong, China.
Fachao ZhiDepartment of Gastroenterology, Guangdong Provincial Key Laboratory of Gastroenterology, Institute of Gastroenterology of Guangdong Province, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue North, Guangzhou, 510515, Guangdong, China. zhifc41532@163.com.

Funding

Bao'an District Medical and Health Research Project of Shenzhen 2022JD024
6 · The paper itself

Abstract

backgroundSingle-use gastrointestinal endoscopes eliminate the need for post-procedure reprocessing and have become an area of interest in endoscopic device development and quality management. However, clinical data on their use in routine gastrointestinal endoscopy remain limited. This prospective, two-center, single-arm study evaluated the feasibility and short-term safety of single-use gastroscopy performed with ENDOANGEL, an artificial intelligence (AI)-based real-time quality monitoring system, and single-use colonoscopy in routine gastrointestinal endoscopy. Formal AI-based quality scoring was applied to gastroscopy, whereas ENDOANGEL-related colonoscopy indicators were recorded descriptively.

resultsA total of 120 participants were enrolled, including 60 who underwent gastroscopy and 60 who underwent colonoscopy. Imaging of predefined anatomical sites was successful in all participants in both groups (60/60 in each group; 95% CI 94.0-100.0%). All procedures were completed without conversion to reusable endoscopes. The overall image quality scores were 39.2 ± 0.8/40 for gastroscopy and 31.3 ± 0.8/32 for colonoscopy. Mean total procedure times were 9.3 ± 2.7 min and 12.6 ± 3.1 min, respectively. No device malfunction, device defect, or procedure-related adverse event was observed during the procedure or within 24 h after endoscopy. In gastroscopy, all ENDOANGEL-assisted examinations achieved the maximum procedural score, and ENDOANGEL-based assessment agreed with manual assessment of imaging success and procedure completion. In colonoscopy, ENDOANGEL-related cecal intubation reminders agreed with manual assessment in all procedures, and withdrawal-speed alerts were recorded in 4 of 60 procedures.

conclusionSingle-use gastroscopy with real-time AI-based quality monitoring and single-use colonoscopy were feasible in routine gastrointestinal endoscopy and showed a favorable short-term safety profile within 24 h. AI-related findings should be interpreted as feasibility and agreement data for gastroscopy and as descriptive process-monitoring observations for colonoscopy. Further controlled studies are needed to compare single-use and reusable systems and to clarify the clinical role of AI-based process monitoring in single-use endoscopy.

trial registrationChinese Clinical Trial Registry, ChiCTR2100045101. Retrospectively registered on April 6, 2021.

Indexed as

Artificial IntelligenceColonoscopyGastroscopyAdultFeasibility StudiesFemaleHumansMaleMiddle AgedProspective StudiesQuality ControlTime FactorsArtificial intelligenceColonoscopyGastroscopyQuality monitoringSingle-use gastrointestinal endoscopyTechnical performance

Identifiers

PMID42393687
PMCPMC13595721

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.