Clinical Trial Data

Performance

In Clinical Use

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Healthcare professionals / Gastroenterology / EXALTTM Model D Single-Use Duodenoscope / Clinical / Clinical Trial Data

 

Clinically Verified1

“We decided to do a trial, even through 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. Brian Dunkin, Chief Medical Officer, Boston Scientific Endoscopy

 

Exalt USA.

60

Human use clinical trial patients

In a consecutive case series of the EXALT Model D Duodenoscope, 60 ERCPs, of all 4 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

EXALT Scope.

96.7%

ERCP procedures completed with EXALT alone

All ERCP procedures were successfully performed, of which 96.7% were completed with the single-use duodenoscope alone and 3.3% with crossover to a reusable duodenoscope.

Exalt Social.

9/10

Median overall satisfaction
with EXALT

The median overall satisfaction with the
single-use duodenoscope by physicians was rated a 9 out of 10

1Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2019 Nov 6. pii: S1542-3565(19)31261-3. doi: 10.1016/j.cgh.2019.10.052. [Epub ahead of print]

   

Dr. Kenneth Binmoeller Comments on the Clinical Trial

Dr. Binmoeller comments on the results of the clinical evaluation of the EXALT Model D Single-Use Duodenoscope and how it helps support the readiness of the device for clinical use. 

   

Evaluating Equivalent Performance of Single-Use and Reusable Duodenoscopes2


“Single-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use [EXALT Model D Single-Use Duodenoscope] and reusable duodenoscopes [Olympus TJF-180] in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).” 2

   

Results:

46/48 icon
46 out of 48 patients were successfully cannulated using the EXALT Model D Single-Use Duodenoscope. 
bulls eye icon
Median number of attempts to achieve successful cannulation was significantly lower for the EXALT Model D Single-Use Duodenoscope..
gear icon
Overall technical performance and safety profile were similar between the EXALT Model D Single-Use Duodenoscope and reusable duodenoscopes.

Conclusion:

trio icon
Given the overall safety profile and similar technical performance, the EXALT Model D Single-Use Duodenoscope represents an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.
2. Bang JY, Hawes, R, Varadarajulu, S. Equivalent performance of single-use and reusable duodenoscopes in a randomized trial. Gut 2020;0:1-7. Doi:10.1136/gutjnl-2020-321836
   

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Watch Dr. Adarsh Thaker present case footage using the EXALT Model D Single-Use Duodenoscope

  
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