Endoscopic Retrograde Cholangiopancreatography
Conditions
Brief summary
The objective of this study is to confirm procedural performance of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures.
Detailed description
The main objective of this study to confirm the design and operating specifications of the Exalt Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures in study subjects.
Interventions
Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (ERCP) or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Scheduled for a clinically indicated endoscopic retrograde cholangiopancreatography (ERCP)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope | Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1. | Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. |
| Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope | Crossover is monitored throughout the procedure (within 24 hours on study day 1). | 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. |
| Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure | SAEs are assessed through 7 days after the procedure. | Number of serious adverse events (SAEs) related to the device and/or the procedure. |
Countries
Netherlands, United States
Participant flow
Pre-assignment details
208 patients provided informed consent for the study, however prior to participation 8 patients were subsequently found to be ineligible and are considered screen failures per protocol.
Participants by arm
| Arm | Count |
|---|---|
| Exalt DScope 01B Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed using the Exalt single use duodenoscope study device. Subjects are considered enrolled after completing the study specific informed consent form.
Exalt Model D Single-Use Duodenoscope: Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device. | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | Exalt DScope 01B | — |
|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 14 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Netherlands | 10 participants | — |
| Region of Enrollment United States | 190 participants | — |
| Sex: Female, Male Female | 103 Participants | — |
| Sex: Female, Male Male | 97 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 20 / 200 |
| serious Total, serious adverse events | 13 / 200 |
Outcome results
Primary
Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (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.
Time frame: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exalt DScope 01B | Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure | 193 Participants |
Secondary
Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope
Endoscopist overall satisfaction rating of the Exalt single-use duodenoscope, as compared to their past experience with marketed reusable duodenoscopes. The overall satisfaction rating is recorded on a scale of 1 (unsatisfied) to 10 (very satisfied), with 1 being the minimum value (worse) and 10 being the maximum value (better). A rating of 1 indicates the endoscopist is unsatisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes. A rating of 10 indicates the endoscopist is very satisfied with the Exalt single-use duodenoscope, as compared to past experience with marketed reusable duodenoscopes.
Time frame: Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exalt DScope 01B | Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope | 7.6 score on a scale | Standard Deviation 2.1 |
Secondary
Number of Participants With 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.
Time frame: Crossover is monitored throughout the procedure (within 24 hours on study day 1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exalt DScope 01B | Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope | 19 Participants |
Secondary
Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure
Number of serious adverse events (SAEs) related to the device and/or the procedure.
Time frame: SAEs are assessed through 7 days after the procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exalt DScope 01B | Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure | 15 Related Serious Adverse Events |