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Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exalt DScope 02 | Experimental | 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. |
|
| 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 ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Procedure success is assessed at the end of the procedure (within 24 hours on study day 1). |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopist Rating | Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best) | 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 a Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope |
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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 |
| Marco Bruno, MD, PhD | Erasmus 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 |
|---|---|---|---|
| 37463599 | Derived | Bruno MJ, Beyna T, Carr-Locke D, Chahal P, Costamagna G, Devereaux B, Giovannini M, Goenka MK, Khor C, Lau J, May G, Muthusamy VR, Patel S, Petersen BT, Pleskow DK, Raijman I, Reddy DN, Repici A, Ross AS, Sejpal DV, Sherman S, Siddiqui UD, Ziady C, Peetermans JA, Rousseau MJ, Slivka A; EXALT Single-use Duodenoscope Study Group. Global prospective case series of ERCPs using a single-use duodenoscope. Endoscopy. 2023 Dec;55(12):1103-1114. doi: 10.1055/a-2131-7180. Epub 2023 Jul 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| 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 | Jan 14, 2022 |
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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. |
| Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1). |
| 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 | SAEs are assessed through 30 days after the procedure. |
| University of Chicago |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Indianapolis University Hospital | Indianapolis | Indiana | 46202 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Cornell Medical Center | New York | New York | 10065 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Metro North Hospital and Health Services | Brisbane | Australia |
| St. Michael's Hospital - Unity Health | Toronto | M5B 1W8 | Canada |
| Institut Paoli-Calmettes | Marseille | France |
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf | North Rhine-Westphalia | Germany |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Asian Institute of Gastroenterology | Hyderabad | Telangana | India |
| Apollo Multispeciality Hospitals | Kolkata | West Bengal | 700054 | India |
| Humanitas University | Milan | Italy |
| Erasmus University Medical Center of Rotterdam | Rotterdam | 3015 CN | Netherlands |
| Singapore General Hospital | Singapore | Singapore |
| Dr. George Mukhari Academic Hospital | Ga-Rankuwa | South Africa |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| American Society of Anesthesiology physical status | PI graded physical status of subjects on the ASA scale from I - IV. ASA I being a normal healthy patient to ASA VI being a brain dead patient. | Count of Participants | Participants |
| |||||||||||||||||
| Relevant gastrointestinal medical history | Number | participants |
|
| 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 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). |
|
|
| |||||||||||||||||||||||||||
| Secondary | Endoscopist Rating | Endoscopist ratings of overall satisfaction with the single-use duodenoscope on a scale of 1 (worst) to 10 (best) | Posted | Median | Full Range | 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. |
|
| |||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | Incidence of crossover is monitored throughout the procedure (within 24 hours on study day 1). |
|
| ||||||||||||||||||||||||||||
| 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 | Posted | Number | Events | SAEs are assessed through 30 days after the procedure. |
|
|
30 Days
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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 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. | 17 | 551 | 85 | 551 | 75 | 551 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastric perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pneumoretroperitoneum | Gastrointestinal disorders | Systematic Assessment |
| ||
| Complication associated with device | General disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Bile duct stenosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Biliary obstruction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile infection | Infections and infestations | Systematic Assessment |
| ||
| Escherichia bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Klebsiella sepsis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Post procedural pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Pseudomonas peritonitis | Infections and infestations | Systematic Assessment |
| ||
| Retroperitoneal abscess | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Gastrointestinal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal stenosis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Haemobilia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Jaundice | Hepatobiliary disorders | Systematic Assessment |
| ||
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Klebsiella infection | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural fever | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural nausea | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural site reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural vomiting | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| White blood cell count increased | Investigations | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Device occlusion | Product Issues | Systematic Assessment |
| ||
| Ovarian cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Weight decreased | Investigations | Systematic Assessment |
| ||
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
|
Limitations include the lack of randomization and the absence of a control group. The enrolled subjects may not be typical of patients at all endoscopy centers. Several investigators participated in the development of the single-use duodenoscope and also received research funding from the study sponsor and from manufacturers of reusable duodenoscopes. Lastly, this study did not address the associated costs or impact on reprocessing services or the environment.
A contractual agreement is in place between the PI and the Sponsor that restricts the right to discuss or publish trial results without prior review by the Sponsor
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Lazzari | Boston Scientific Corporation | 508-382-9132 | victoria.lazzari@bsci.com |
| Oct 24, 2023 |
| Prot_SAP_002.pdf |
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| Sex, other |
|
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| Singapore |
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| Hong Kong |
|
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| United States |
|
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| Italy |
|
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| South Africa |
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| Australia |
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| France |
|
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| Germany |
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| India |
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| II |
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| III |
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| IV |
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| V |
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| Not assessed |
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| Current immunosuppression (any cause) |
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| Chronic pancreatitis |
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| Pancreatic tumor |
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| Abnormal image finding |
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| Cholangitis (current) |
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| Cholangiocarcinoma |
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| Primary sclerosing cholangitis |
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| Other gastrointestinal cancer |
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| Pancreatic stones (current) |
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| Recurrent cholangitis |
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| Hepatic tumor |
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| Hepatitis |
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| Pancreatic pseudocyst |
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| Known history of Multidrug-resistant organisms (MDRO) colonization |
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| Known current MDRO colonization |
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| Current documented bacterial infection, other than cholangitis |
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| Other |
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