Endoscopic Retrograde Cholangiopancreatography
Conditions
Brief summary
Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based 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. Up to 1000 cases will be included at up to 40 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 30 days after their procedure.
Interventions
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.
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 ERCP
Exclusion criteria
* 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 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 Rating | Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1. | Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best) |
| Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope | Incidence of 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 Adverse Events (SAEs) Related to the Device and/or the Procedure | SAEs are assessed through 30 days after the procedure. | Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures |
Countries
Australia, Canada, France, Germany, Hong Kong, India, Italy, Netherlands, Singapore, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exalt DScope 02 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. | 551 |
| Total | 551 |
Baseline characteristics
| Characteristic | Exalt DScope 02 | — |
|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 15.9 | — |
| American Society of Anesthesiology physical status I | 66 Participants | — |
| American Society of Anesthesiology physical status II | 198 Participants | — |
| American Society of Anesthesiology physical status III | 250 Participants | — |
| American Society of Anesthesiology physical status IV | 32 Participants | — |
| American Society of Anesthesiology physical status Not assessed | 5 Participants | — |
| American Society of Anesthesiology physical status V | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 25 participants | — |
| Region of Enrollment Canada | 25 participants | — |
| Region of Enrollment France | 25 participants | — |
| Region of Enrollment Germany | 25 participants | — |
| Region of Enrollment Hong Kong | 25 participants | — |
| Region of Enrollment India | 50 participants | — |
| Region of Enrollment Italy | 25 participants | — |
| Region of Enrollment Netherlands | 25 participants | — |
| Region of Enrollment Singapore | 25 participants | — |
| Region of Enrollment South Africa | 25 participants | — |
| Region of Enrollment United States | 276 participants | — |
| Relevant gastrointestinal medical history Abnormal image finding | 60 participants | — |
| Relevant gastrointestinal medical history Bile duct stones/gallstones(current) | 168 participants | — |
| Relevant gastrointestinal medical history Cholangiocarcinoma | 46 participants | — |
| Relevant gastrointestinal medical history Cholangitis (current) | 53 participants | — |
| Relevant gastrointestinal medical history Chronic pancreatitis | 68 participants | — |
| Relevant gastrointestinal medical history Current documented bacterial infection, other than cholangitis | 8 participants | — |
| Relevant gastrointestinal medical history Current immunosuppression (any cause) | 71 participants | — |
| Relevant gastrointestinal medical history Documented biliary or pancreatic stricture, unresolved | 124 participants | — |
| Relevant gastrointestinal medical history Hepatic tumor | 18 participants | — |
| Relevant gastrointestinal medical history Hepatitis | 11 participants | — |
| Relevant gastrointestinal medical history Known current MDRO colonization | 2 participants | — |
| Relevant gastrointestinal medical history Known history of Multidrug-resistant organisms (MDRO) colonization | 2 participants | — |
| Relevant gastrointestinal medical history Other | 146 participants | — |
| Relevant gastrointestinal medical history Other gastrointestinal cancer | 22 participants | — |
| Relevant gastrointestinal medical history Pancreatic pseudocyst | 9 participants | — |
| Relevant gastrointestinal medical history Pancreatic stones (current) | 22 participants | — |
| Relevant gastrointestinal medical history Pancreatic tumor | 63 participants | — |
| Relevant gastrointestinal medical history Primary sclerosing cholangitis | 24 participants | — |
| Relevant gastrointestinal medical history Recurrent cholangitis | 21 participants | — |
| Sex/Gender, Customized Sex, Female | 269 Participants | — |
| Sex/Gender, Customized Sex, Male | 281 Participants | — |
| Sex/Gender, Customized Sex, other | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 551 |
| other Total, other adverse events | 75 / 551 |
| serious Total, serious adverse events | 85 / 551 |
Outcome results
Primary
Number of Participants With 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.
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 02 | Number of Participants With Successful ERCP Procedure | 529 Participants |
Secondary
Endoscopist Rating
Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best)
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 (MEDIAN) |
|---|---|---|
| Exalt DScope 02 | Endoscopist Rating | 8.0 Score on a scale |
Secondary
Number of Adverse Events (SAEs) Related to the Device and/or the Procedure
Evaluation of serious adverse events (SAEs) related to the device and/or the procedure through 30 days after the ERCP or other duodenoscope based procedures
Time frame: SAEs are assessed through 30 days after the procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exalt DScope 02 | Number of Adverse Events (SAEs) Related to the Device and/or the Procedure | 46 Events |
Secondary
Number of Participants With a 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: Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exalt DScope 02 | Number of Participants With a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope | 37 Participants |