ArticleAnnals of gastroenterology
Clinical adverse events and device failures for the Barrx™ radiofrequency ablation catheter system: a MAUDE database analysis.
Article in Annals of gastroenterology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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.
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Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Local hyperthermia mediated by gold nanoparticle-integrated silicone-covered stent: feasibility and tissue response in a rat esophageal model.European radiology experimental · 2024Article
- Atrial Flutter After Radiofrequency Ablation for Barrett's Esophagus: A Case Report.The American journal of case reports · 2023Article
- Endoscopic Management of Dysplastic Barrett's Oesophagus and Early Oesophageal Adenocarcinoma.Cancers · 2023Review
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The Barrx™ radiofrequency ablation (RFA) catheter system comes in several different variations and sizes and is widely used for the eradication of Barrett's esophagus (BE). The Barrx™ 360 and 360 Express system is used to perform circumferential RFA, while the Barrx™ focal catheter system is used for secondary focal RFA or primary treatment of short-segment BE. We aimed to investigate the number and type of complications and device failures associated with the Barrx™ RFA catheter system. Method: We analyzed post-marketing surveillance data from the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from August 2011 to August 2021. Results: During the study period, 148 unique reports detailing 78 device issues and 87 patient-related adverse events were identified. The most reported adverse events for patients were stenosis secondary to treatment (n=15, 17.24%), mucosal laceration of the esophagus (n=13, 14.94%), chest pain (n=10, 11.49%), and odynophagia/dysphagia (n=7, 8.05%). The most common device complication was failure of the device to deploy when activated (n=10, 13.82%). Other device malfunctions included material deformation/distortion (n=7, 8.97%), catheter breakage (n=6, 7.69%), connection problems between the generator cable and RFA device (n=6, 7.69%), and failure of the balloon to properly inflate (n=5, 6.41%). Conclusion: Findings from the MAUDE database highlight patient and device complications that endoscopists should be aware of prior to RFA of BE with the Barrx™ RFA catheter system.
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Registered trials
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.