Endoscopic Retrograde CholangiopancreatographyNCT03701958
Initial Case Series With Exalt Single-Use Duodenoscope
A study testing Exalt Model D Single-Use Duodenoscope in people with Endoscopic Retrograde Cholangiopancreatography, run by Boston Scientific Corporation at 6 sites in United States.
Trial summary
To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- Exalt Model D Single-Use Duodenoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Apr 2019to 7 Jun 2019
- 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.
- Scheduled for a clinically indicated ERCP
Who cannot join
- Altered pancreaticobiliary anatomy
- Potentially vulnerable subjects, including, but not limited to pregnant women
- Subjects for whom endoscopic techniques are contraindicated
- Patients 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, 90095
North Shore University Hospital
Manhasset, New York, 11030
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.
Read the detailed description
This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 7 days after their procedure.
- Being tested
- Exalt Model D Single-Use Duodenoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exalt Model D Single-Use DuodenoscopeDevice
Subjects will have a clinically indicated per standard of care ERCP procedure performed with the Exalt single use duodenoscope study device.
| Study group | Role | What they receive |
|---|---|---|
| Exalt DScope 01 | Other | Subjects will have a clinically indicated per standard of care ERCP procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. Receives: Device: Exalt Model D Single-Use Duodenoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful 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.
Measured: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
Secondary outcomes (3)
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.
Measured: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1).
Incidence of 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.
Measured: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
Evaluation of adverse events (SAEs) related to the device and/or the procedure
Measured: SAEs are assessed through 7 days after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start15 Apr 2019
- Primary completion6 May 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Retrograde 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- V. Raman Muthusamy, MD, Principal investigator, University of California, Los AngelesAndrew Ross, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701958
- Sponsor's protocol ID
- E7145
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.
PubMed 31706060
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Case Series With Exalt Single-Use Duodenoscope
- ClinicalTrials.gov ID
- NCT03701958
- Acronym / sponsor ID
- E7145
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 10 Oct 2018 (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.
To confirm procedural performance of the Exalt single-use duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures.
Detailed description
This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. 35-70 cases will be included at up to 10 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 7 days after their procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exalt DScope 01 | Other | Device: Exalt Model D Single-Use DuodenoscopeSubjects will have a clinically indicated per standard of care ERCP procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form. |
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.
- Scheduled for a clinically indicated ERCP
Key exclusion criteria (5 listed)
- Altered pancreaticobiliary anatomy
- Potentially vulnerable subjects, including, but not limited to pregnant women
- Subjects for whom endoscopic techniques are contraindicated
- Patients 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 |
|---|---|---|
| Exalt Model D Single-Use DuodenoscopeSubjects will have a clinically indicated per standard of care ERCP procedure performed with the Exalt single use duodenoscope study device. | Device | Exalt DScope 01 |
Primary outcome
Successful ERCP procedure
Time frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
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.
3 secondary outcomes
Endoscopist qualitative rating
Time frame: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure (within 24 hours on study day 1).
Incidence of crossover from Exalt single-use duodenoscope to reusable duodenoscope
Time frame: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
Evaluation of adverse events (SAEs) related to the device and/or the procedure
Time frame: SAEs are assessed through 7 days after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 31706060Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2108-2117.e3. doi: 10.1016/j.cgh.2019.10.052. Epub 2019 Nov 6.
- Individual participant dataSharing planned: No
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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.
V. Raman Muthusamy, MD principal investigator
University of California, Los Angeles
Andrew Ross, MD principal investigator
Virginia Mason Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exalt Model D Single-Use Duodenoscope in people with Endoscopic Retrograde Cholangiopancreatography, run by Boston Scientific Corporation at 6 sites in United States.
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 5 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: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful ERCP procedure (time frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701958, which also lists 1 linked publication.
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 8 Feb 2022.