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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exalt DScope 01B | Experimental | Subjects will have a clinically indicated per standard of care endoscopic retrograde cholangiopancreatography (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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exalt Model D Single-Use Duodenoscope | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Procedure success is assessed at the end of the procedure (within 24 hours on study day 1). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Slivka, MD, PhD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles Medical Center | Los Angeles | California | 90095 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34186052 | Derived | Slivka A, Ross AS, Sejpal DV, Petersen BT, Bruno MJ, Pleskow DK, Muthusamy VR, Chennat JS, Krishnamoorthi R, Lee C, Martin JA, Poley JW, Cohen JM, Thaker AM, Peetermans JA, Rousseau MJ, Tirrell GP, Kozarek RA; EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021 Dec;94(6):1046-1055. doi: 10.1016/j.gie.2021.06.017. Epub 2021 Jun 26. |
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The data, analytic methods, and study materials for this study may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2020 |
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| Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1. |
| 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. | Crossover is monitored throughout the procedure (within 24 hours on study day 1). |
| 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. | SAEs are assessed through 7 days after the procedure. |
| Beth Israel Deaconess Medical Center |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Erasmus Medical Center | Rotterdam | Netherlands |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Procedure success is assessed at the end of the procedure (within 24 hours on study day 1). |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Endoscopists will rate their experience with the Exalt single-use duodenoscope immediately following the completion of the study procedure on study day 1. |
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| 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. | Posted | Count of Participants | Participants | Crossover is monitored throughout the procedure (within 24 hours on study day 1). |
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| 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. | Posted | Number | Related Serious Adverse Events | SAEs are assessed through 7 days after the procedure. |
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Occurrence of adverse events were collected through 7 days (+/- 2 days) after the index procedure.
All adverse events were collected, regardless of relationship to study device and/or procedure. Given the nature of the study procedure, any crossover between the Exalt single-use duodenoscope and the reusable duodenoscope would have occurred during the same study procedure therefore, it is difficult to determine the relatedness of adverse events to the Exalt single-use duodenoscope or to the reusable duodenoscope. Adverse events are therefore reported in a combined fashion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 200 | 13 | 200 | 20 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA (22.0) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Oesophageal mucosal tear | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Fever | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Abnormal faeces | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Lazzari | Boston Scientific | 508-382-9132 | victoria.lazzari@bsci.com |
| Mar 1, 2022 |
| Prot_SAP_002.pdf |
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