ArticleClinical endoscopy2026
First-in-human European experience with novel 22-G end-cutting fine-needle biopsy system: a prospective observational pilot study.
Article in Clinical endoscopy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
backgroundEndoscopic ultrasound (EUS)-guided biopsy remains a cornerstone for diagnosing and staging gastrointestinal diseases. Various systems are available, with needle designs for fine-needle aspiration and fine-needle biopsy (FNB) and gauges from 25-G to 19-G. We aimed to report the first European human experience with a novel 22-G end-cutting FNB system (EchoTip ClearCore; Cook Medical).
methodsThis prospective observational study was conducted at our tertiary endoscopy center between November and December 2024. All patients undergoing EUS-guided puncture with the 22-G EchoTip ClearCore needle were included. User and patient experience were assessed using questionnaires. Clinical data were obtained from electronic hospital records.
resultsTen patients underwent 15 EUS-guided biopsies. The median patient age was 57 (range, 18-77) years, and 60% were male. Indications included liver biopsy for elevated liver enzymes or post-transplantation assessment (67%), evaluation of pancreatic lesions (20%), and sampling of pathological lymph nodes (13%). The technical success rate was 100%. Specimen quality was sufficient for diagnosis in 93% of cases. Operators rated the needle highly for EUS visibility (8.8/10), maneuverability and stability (7.9/10), and ease of tissue penetration (8.3/10). Overall patient satisfaction was high (5/5); no complications occurred.
conclusionsThe 22-G EchoTip ClearCore needle is safe and effective, demonstrating excellent technical and clinical outcomes.
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