CholangiopancreatographyExaltDScopeNCT04687774
Exalt D Single-use Duodenoscope in ERCP Procedures in China
A study testing ExaltTM Model D Single-Use Duodenoscope in people with Cholangiopancreatography, run by Boston Scientific Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiopancreatography
- What is being tested?
- ExaltTM Model D Single-Use Duodenoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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).
- Conditions
- Cholangiopancreatography
- Being tested
- ExaltTM Model D Single-Use Duodenoscope
- Keywords
- ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExaltTM Model D Single-Use DuodenoscopeDevice
Also called ExaltTM Controller
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ExaltTM Model D Single-Use Duodenoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the procedure
Secondary outcomes (1)
Endoscopist qualitative rating
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.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study startAug 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiopancreatographyStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, Principal investigator, Boao Super Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687774
- Sponsor's protocol ID
- E7164
- Acronym
- ExaltDScope
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2020
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Exalt D Single-use Duodenoscope in ERCP Procedures in China
- ClinicalTrials.gov ID
- NCT04687774
- Acronym / sponsor ID
- ExaltDScope / E7164
- Conditions
- Cholangiopancreatography
- Keywords
- ERCP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategy Adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm study | Experimental | Device: ExaltTM Model D Single-Use DuodenoscopeA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExaltTM Model D Single-Use DuodenoscopeAlso: ExaltTM ControllerThe 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. | Device | single-arm study |
Primary outcome
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).
1 secondary outcome
Endoscopist qualitative rating
Time frame: During the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoshen Li principal investigator
Boao Super Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ExaltTM Model D Single-Use Duodenoscope in people with Cholangiopancreatography, run by Boston Scientific Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients complete the ERCP procedure (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.