EXALT Model D peer-reviewed, published data, includes one trial where patients were consecutively enrolled. Explore the data and get physician perspectives about high-risk patient selection.
Muthusamy VR, et al. | Clin Gastroenterol Hepatol. 2020
In a consecutive case series testing the feasibility, preliminary safety, and performance of a single-use duodenoscope, 60 ERCPs of all four ASGE complexity levels were completed across six sites in the United States for indications including pancreaticobiliary stone clearance, stent placement, exchange and/or removal and balloon dilation.1
100%
100% of ERCP procedures were successfully performed96.7%
96.7% of ERCP procedures were completed with EXALT Model D alone and 3.3% with crossover to a reusable duodenoscope9/10
The median overall physician satisfaction for the EXALT Model D Single-Use duodenoscope scope by physicians was 9 out of 10
“We decided to do a trial, even though it wasn’t mandated by the FDA which is fairly unprecedented. We wanted to reassure physicians that EXALT Model D was not going to compromise the quality of the procedure. We had expert clinicians, who know the nuances of the procedure, confirm that EXALT Model D performed as expected. The feedback we received from clinicians as part of this trial was invaluable.”
Dr. Kenneth Binmoeller discusses the clinical evaluation of the EXALT Model D Single-Use Duodenoscope and how it helps support the readiness of the device for clinical use.
Bang JY, et al. | Gut 2020
This randomised trial of 98 patients compared the performance of the EXALT Model D Single-Use Duodenoscope with reusable duodenoscopes in patients undergoing ERCP.
Napolean N, et al. | Digestive Endoscopy 2021
In a consecutive case series evaluating the feasibility, safety and performance of a single-use duodenoscope, 60 ERCPs of all four ASGE complexity levels were completed across six sites in France for indications including pancreaticobiliary stone clearance, stent placement and/or removal and balloon dilation.
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