Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial

Conditions

• Biliary Diseases
• Pancreatic Duct Disorder

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Exalt Model D — DEVICE
  Exalt Model D single-use duodenoscope will be used in ERCP
• Reusable — DEVICE
  Standard reusable duodenoscope will be used in ERCP

Study Details

This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Key Dates

Start date

Feb 21, 2025

Status verified

Mar 2025

Primary completion

Feb 28, 2030

Completion

May 31, 2030

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Exalt Model D
  Exalt Model D single use duodenoscope will be used for ERCP
• Active Comparator: Standard Reusable
  Standard reusable model of duodenoscope will be used for ERCP

Primary Outcome Measure

Number of attempts required to achieve successful cannulation of the desired duct [ Time Frame: From the time of the ERCP to 7 days post-ERCP per standard of care ]

Central Contacts

• Neal A Mehta, MD
  3129428651
  [email protected]
• Amanda F Lin
  3125633907
  [email protected]

Locations (1)

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