NCT04040504

Brief Summary

  1. 1.Background \& Rationale
  2. 2.Research Questions \& Objectives
  3. 3.Methods

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 3, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

July 29, 2019

Last Update Submit

June 25, 2022

Conditions

Bile Duct Diseases

Outcome Measures

Primary Outcomes (2)

  • ERCP technical success rate

    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.

    Immediate

  • Persistent bacterial contamination rate

    Persistent bacterial contamination will be assessed following standardized disinfection and reprocessing using microbiologic swabs and culturing.

    Immediate

Study Arms (2)

Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)

EXPERIMENTAL

Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)

Device: ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)

Pentax ED-34i10T Duodenoscope

ACTIVE COMPARATOR

Pentax ED-34i10T Duodenoscope

Device: ERCP procedure with Pentax ED-34i10T Duodenoscope

Interventions

ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)DEVICE

ERCP procedure using Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC) and any necessary accessories.

Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)
ERCP procedure with Pentax ED-34i10T DuodenoscopeDEVICE

ERCP procedure using Pentax ED-34i10T Duodenoscope with any necessary accessories.

Pentax ED-34i10T Duodenoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter Lougheed Centre

Calgary, Canada

Location

Related Publications (2)

  • Forbes N, Elmunzer BJ, Allain T, Parkins MD, Sheth PM, Waddell BJ, Du K, Douchant K, Oladipo O, Saleem A, Cartwright S, Chau M, Howarth M, McKay J, Nashad T, Ruan Y, Bishay K, Gonzalez-Moreno E, Meng ZW, Bass S, Bechara R, Cole MJ, Jalink DW, Mohamed R, Turbide C, Belletrutti PJ, Kayal A, Kumar PR, Hilsden RJ, Buret AG, Hookey L, Heitman SJ. Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):191-200. doi: 10.1001/jamainternmed.2022.6394.

    PMID: 36689215DERIVED

  • Forbes N, Elmunzer BJ, Allain T, Chau M, Koury HF, Bass S, Belletrutti PJ, Cole MJ, Gonzalez-Moreno E, Kayal A, Kumar P, Mohamed R, Turbide C, Buret AG, Heitman SJ. Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial. BMC Gastroenterol. 2020 Mar 12;20(1):64. doi: 10.1186/s12876-020-01200-7.

    PMID: 32164535DERIVED

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Nauzer Forbes, MD MSc

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Medicine

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

December 3, 2019

Primary Completion

February 28, 2022

Study Completion

March 31, 2022

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)