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Clinical Trials/NCT04628949
NCT04628949CompletedNot Applicable

A Single-Use Duodenoscope in a Real-World Setting

Ambu A/S18 sites in 1 country248 target enrollmentStarted: January 25, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Ambu A/S
Enrollment
248
Locations
18
Primary Endpoint
To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.

Detailed Description

This is a prospective, non-randomized, single-arm post-market observational clinical study that will assess the single-use Ambu® aScope™ Duodeno for non-emergent, standard of care (SOC) ERCP procedures.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subject is ≥ 18 years old.
  • •Subject is indicated and scheduled for an elective, non-emergent ERCP.
  • •Subject is willing and able to give informed consent and HIPAA authorization.

Exclusion Criteria

  • •Subject has altered pancreaticobiliary anatomy including:
  • •Billroth II
  • •Roux-en-Y gastric bypass
  • •Loop gastric bypass
  • •Post-Whipple
  • •Roux-en-Y hepaticojejunostomy
  • •Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
  • •Subject has any of the following severe co-morbid conditions
  • •Morbid obesity (BMI ≥ 40)
  • •Unstable cardiopulmonary conditions
  • •Severe and uncorrectable coagulopathy
  • •Severe and uncorrectable thrombocytopenia
  • •Subject has clinically significant esophageal, pyloric or duodenal strictures.
  • •Subject has been previously been treated under this investigational plan.
  • •Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
  • •Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
  • •Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.

Outcomes

Primary Outcomes

To evaluate the ERCP procedural success rates with the aScope™ Duodeno endoscope when completing the ERCP procedure for the intended indication(s).

Time Frame: Procedure Completion (Day 0)

Procedure success will be defined as the successful completion of the ERCP procedure with the aScope™ Duodeno endoscope. The procedural success rate will be the incidence rate of success for the ERCP procedure.

Secondary Outcomes

  • To evaluate the device deficiency rate for the aScope™ Duodeno endoscope.(Procedure Completion (Day 0))
  • To evaluate physician satisfaction with the aScope™ Duodeno endoscope.(Procedure Completion (Day 0))
  • To evaluate rate of conversion to a reusable endoscope, other endoscope or an open procedure from the aScope™ Duodeno endoscope during the ERCP procedure.(Procedure Completion (Day 0))
  • To establish comprehensive performance attributes of aScope™ Duodeno endoscope through its use by multiple endoscopists in conducting various ERCP procedures.(Procedure Completion (Day 0))
  • To evaluate rate of successful completion of a converted ERCP procedure.(Procedure Completion (Day 0))

Investigators

Sponsor
Ambu A/S
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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