Exalt D Single-use Duodenoscope in ERCP Procedures in China

NCT04687774 | Withdrawn FDA Device

• 1 other identifier: E7164
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Objective(s)：This study is to evaluate the feasibility, preliminary safety and performance of Exalt D Single-use Duodenoscope in ERCP procedures in China, to generate local real world data from a Chinese ERCP population. Study Design：Prospective, single-arm study Planned Number of Subjects：Up to 35 to satisfy 30 treated cohort Primary Endpoint：Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope. It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D).

Conditions

Cholangiopancreatography

Keywords

ERCP

Outcome Measures

Primary Outcomes (1)

• Number of patients complete the ERCP procedure

  Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope. It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D).

  During the procedure

Secondary Outcomes (1)

• Endoscopist qualitative rating

  During the procedure

Study Arms (1)

single-arm study

EXPERIMENTAL

A single-arm of 30 treated patients is appropriate to generate additional local data on Exalt D Single-use Duodenoscope, since there is existing information in the previous study of Exalt D Single-use Duodenoscope in ERCP procedures and clinical literature regarding its performance.

Device: ExaltTM Model D Single-Use Duodenoscope

Interventions

ExaltTM Model D Single-Use Duodenoscope DEVICE

The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an Exalt™ Controller.

Also known as: ExaltTM Controller

single-arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Schedule for a clinically indicated ERCP

You may not qualify if:

• Potentially vulnerable subjects, including, but not limited to pregnant women
• Subjects for whom endoscopic techniques are contraindicated
• Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
• Investigator discretion

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Officials

• Zhaoshen Li

  Boao Super Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 29, 2020
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 17, 2025

Record last verified: 2025-11