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Trial record 3 of 44 for:    ICECAP

Infection Control in ERCP Using a Duodenoscope With a Disposable Cap (ICECAP)

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ClinicalTrials.gov Identifier: NCT04040504
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Nauzer Forbes, University of Calgary

Brief Summary:
  1. Background & Rationale

    Over 650,000 endoscopic retrograde cholangio-pancreatography (ERCP) procedures are performed annually in the United States alone. ERCP is universally performed using a highly specialized type of flexible endoscope called a duodenoscope. Though critical for the successful completion of ERCP, the design of duodenoscopes makes them among the most complicated medical devices that require routine disinfection and reprocessing. In recent years, several ERCP-related infectious outbreaks have occurred.

    Thus, it is clear that novel strategies need to be developed in order to prevent future ERCP-related outbreaks. Specialized duodenoscopes with disposable caps have been developed, and these represent a promising new modality with the potential to drastically reduce the rates of duodenoscope-related infection.

  2. Research Questions & Objectives

    There are two co-primary outcomes in this study; the first is to determine the clinical efficacy of a novel duodenoscope with a disposable elevator cap (DEC) system compared with a duodenoscope with a traditional design. The second co-primary objective is to determine the rate of persistent pathogenic contamination of the novel duodenoscope following standardized disinfection and reprocessing protocols compared with a traditional duodenoscope.

  3. Methods

This is a prospective, consecutive, randomized controlled study. The intervention arm will comprise use of the ED34-i10T2 duodenoscope with DEC, along with any required standard ERCP accessories, whereas the control arm will comprise use of the ED34-i10T duodenoscope with any required ERCP accessories. All procedures will be performed by expert endoscopists with adequate training, or by advanced endoscopy trainees under direct supervision.

Collected data will include primary endpoints listed above, in addition to patient demographics, endoscopist and trainee data, sedation used, procedural details, and peri-procedural data. Data will be collected at index procedure and at 30-day follow-up. All data will be recorded on REDCap.


Condition or disease Intervention/treatment Phase
Bile Duct Diseases Device: ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC) Device: ERCP procedure with Pentax ED-34i10T Duodenoscope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The patient, investigator and outcomes assessors will be blinded to the intervention. The endoscopist will not be blinded, since the type of scope and cap being used can be detected during the procedure.
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Infection Risk of ERCP Using a Novel Duodenoscope With a Disposable Cap: a Randomized Controlled Trial
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
Device: ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
ERCP procedure using Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC) and any necessary accessories.

Active Comparator: Pentax ED-34i10T Duodenoscope
Pentax ED-34i10T Duodenoscope
Device: ERCP procedure with Pentax ED-34i10T Duodenoscope
ERCP procedure using Pentax ED-34i10T Duodenoscope with any necessary accessories.




Primary Outcome Measures :
  1. ERCP technical success rate [ Time Frame: Immediate ]
    Technical success will be determined in duplicate by two blinded outcome adjudicators with no knowledge of the patient's allocation in the study. The adjudicators will review redacted and de-identified procedure reports for each study patient, and determine the presence or absence of technical success of the overall procedure based on a set of a priori definitions.

  2. Persistent bacterial contamination rate [ Time Frame: Immediate ]
    Persistent bacterial contamination will be assessed following standardized disinfection and reprocessing using microbiologic swabs and culturing.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years or over;
  • ability to give informed consent to involvement;
  • requirement for ERCP to be performed for any indication.

Exclusion Criteria:

  • age < 18 years;
  • inability or unwillingness to provide informed consent;
  • standard contraindications to ERCP;
  • pregnant status or breastfeeding mother;
  • inability to successfully complete procedure under conscious sedation;
  • out-of-province status;
  • incarceration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040504


Contacts
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Contact: Nauzer Forbes, MD MSc 403-592-5089 nauzer.forbes@ucalgary.ca
Contact: Millie Chau, BSvc 403-943-5429 millie.chau@ucalgary.ca

Locations
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Canada
Peter Lougheed Centre Recruiting
Calgary, Canada
Contact: Nauzer Forbes         
Sponsors and Collaborators
University of Calgary
Medical University of South Carolina
Investigators
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Principal Investigator: Nauzer Forbes, MD MSc University of Calgary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nauzer Forbes, Clinical Assistant Professor of Medicine, University of Calgary
ClinicalTrials.gov Identifier: NCT04040504    
Other Study ID Numbers: REB19-0983
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases