Trial Outcomes & Findings for Initial Case Series With Exalt Single-Use Duodenoscope - Expanded User Experience (NCT NCT04223830)

Last Updated: 2022-03-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).

Results posted on

2022-03-31

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	200
Overall Study COMPLETED	190
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	9
Overall Study Adverse Event	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exalt DScope 01B n=200 Participants 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.
Age, Continuous	62.6 years STANDARD_DEVIATION 14.0 • n=200 Participants
Sex: Female, Male Female	103 Participants n=200 Participants
Sex: Female, Male Male	97 Participants n=200 Participants
Region of Enrollment Netherlands	10 participants n=200 Participants
Region of Enrollment United States	190 participants n=200 Participants

PRIMARY outcome

Timeframe: Procedure success is assessed at the end of the procedure (within 24 hours on study day 1).

Outcome measures

Outcome measures
Measure	Exalt DScope 01B n=200 Participants 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.
Number of Participants With Successful Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedure	193 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exalt DScope 01B n=200 Participants 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.
Endoscopist Overall Satisfaction Rating of the Exalt Single-use Duodenoscope	7.6 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Exalt DScope 01B n=200 Participants 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.
Number of Participants With Crossover From Exalt Single-use Duodenoscope to Reusable Duodenoscope	19 Participants

SECONDARY outcome

Timeframe: SAEs are assessed through 7 days after the procedure.

Number of serious adverse events (SAEs) related to the device and/or the procedure.

Outcome measures

Outcome measures
Measure	Exalt DScope 01B n=200 Participants 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.
Number of Serious Adverse Events (SAEs) Related to the Device and/or the Procedure	15 Related Serious Adverse Events

Adverse Events

Exalt DScope 01B

Serious events: 13 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Exalt DScope 01B n=200 participants at risk 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.
Gastrointestinal disorders Abdominal pain	1.0% 2/200 • Number of events 2 • 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.
Infections and infestations Pneumonia	0.50% 1/200 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	0.50% 1/200 • Number of events 1 • 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.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.0% 2/200 • Number of events 2 • 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.
Hepatobiliary disorders Bile duct stone	0.50% 1/200 • Number of events 1 • 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.
Hepatobiliary disorders Cholangitis	1.0% 2/200 • Number of events 2 • 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.
Gastrointestinal disorders Pancreatitis	1.5% 3/200 • Number of events 3 • 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.
Gastrointestinal disorders Oesophageal mucosal tear	0.50% 1/200 • Number of events 1 • 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.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.50% 1/200 • Number of events 1 • 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.
Infections and infestations Escherichia urinary tract infection	0.50% 1/200 • Number of events 1 • 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.
General disorders Systemic inflammatory response syndrome	0.50% 1/200 • Number of events 1 • 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.
Gastrointestinal disorders Mallory-Weiss syndrome	0.50% 1/200 • Number of events 1 • 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.
Infections and infestations Fever	0.50% 1/200 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Exalt DScope 01B n=200 participants at risk 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.
Gastrointestinal disorders Abdominal Pain	4.0% 8/200 • Number of events 8 • 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.
Gastrointestinal disorders Pancreatitis	2.5% 5/200 • Number of events 5 • 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.
Gastrointestinal disorders Diarrhoea	1.0% 2/200 • Number of events 2 • 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.
Gastrointestinal disorders Nausea	0.50% 1/200 • Number of events 1 • 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.
Gastrointestinal disorders Haematochezia	0.50% 1/200 • Number of events 1 • 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.
Gastrointestinal disorders Dysphagia	0.50% 1/200 • Number of events 1 • 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.
Gastrointestinal disorders Dyspepsia	0.50% 1/200 • Number of events 1 • 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.
Gastrointestinal disorders Abnormal faeces	0.50% 1/200 • Number of events 1 • 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.
Eye disorders Conjunctival haemorrhage	0.50% 1/200 • Number of events 1 • 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.

Additional Information

Victoria Lazzari

Boston Scientific

Phone: 508-382-9132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60