- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04687774
Exalt D Single-use Duodenoscope in ERCP Procedures in China (ExaltDScope)
Real World Study of Exalt D Single-use Duodenoscope in ERCP Procedures in China
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Device Description: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.
The Exalt™ Controller is an electronic device that:
- Receives video signals from a Boston Scientific single-use endoscope,
- Processes the video signals,
- Outputs video images to a video monitor, and
- Outputs electrical signal(s) that interface with external image capture systems.
Study Design:This is a prospective, single-arm study with up to 35 subjects to satisfy 30 treated cohort in up to 3 centers. The study duration is expected to be approximately 7 months, assuming 6 months enrollment and 1 month follow up. The study duration for each subject is expected to be approximately 30 days.
Data Analyses:All statistical analyses will be done using The SAS System software, version 8 or higher (Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, USA. All rights reserved).
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single-arm study
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients complete the ERCP procedure
Time Frame: During the 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endoscopist qualitative rating
Time Frame: During the procedure
|
Endoscopist rating of the Exalt single-use duodenoscope compared to their past experience with marketed reusable duodenoscopes as it pertains to various design and performance related attributes.
Besides those criteria similar to Exalt DScope 01 study, assessment in this study will include imaging quality (brightness, color, photometry), overall maneuverability and overall satisfaction, which will be rated from 1-10, where 1 is the worst and 10 is the best.
|
During the procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhaoshen Li, Boao Super Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E7164
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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