Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Study arms

• Experimental
  Exalt DScope 01B

  Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.

  Device: Exalt Model D Single-Use Duodenoscope

Interventions

• DeviceExalt Model D Single-Use Duodenoscope

  Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.

Primary outcomes

1. Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure

   The ability to complete the ERCP procedure for the intended indication(s); outcome reported as "success" or "failure". Examples include but are not limited to: biliary stent placement, pancreatic stent placement, sphincterotomy, and clearance of bile duct stones.

   Time frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).

Secondary outcomes

1. Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope

   Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.

   Time frame: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.

2. Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope

   The need to use a reusable duodenoscope for any task which cannot be adequately performed with the Exalt single-use duodenoscope is considered a crossover.

   Time frame: Crossover is monitored throughout the procedure (within 24 hours on study day 1).

3. Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure

   Number of serious adverse events (SAEs) related to the device and/or the procedure.

   Time frame: SAEs are assessed through 7 days after the procedure.

Baseline characteristics

Publications

• Slivka A, Ross AS, Sejpal DV, Petersen BT, Bruno MJ, Pleskow DK, Muthusamy VR, Chennat JS, Krishnamoorthi R, Lee C, Martin JA, Poley JW, Cohen JM, Thaker AM, Peetermans JA, Rousseau MJ, Tirrell GP, Kozarek RA; EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26. PubMed 34186052 ↗

Study documents

• Protocol and statistical analysis plan · Aug 13, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The data, analytic methods, and study materials for this study may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).