MedTrace Logo

Duodenoscope Disinfect Study

NCT02611648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2017-03-14

No results posted yet for this study

Summary

This study is investigating the most effective way to sterilize duodenoscopes ("scopes") used at Beth Israel Deaconess Medical Center (BIDMC). Right now, BIDMC uses the standard method of high level disinfection to sterilize scopes. Because infections have been passed by scopes at other institutions in the U.S., the investigators are exploring whether or not adding two different sterilization processes will reduce this risk of contamination.

Bacteria may be passed from a patient's intestines to the scope. Or, if the scope is contaminated, bacteria may be passed from the scope to the patient. In order to understand how bacteria are passed, the investigators will be taking samples of the patient's intestinal bacteria to compare to the bacteria, if any, found on the scope.

Conditions

  • Endoscopic Retrograde Cholangiopancreatogram (ERCP)

Interventions

OTHER

Double HLD

Standard high level disinfectant (metricide ortho-phthalaldehyde) with an additional exposure time to disinfect

OTHER

HLD/ETO

Standard high level disinfectant (metricide ortho-phthalaldehyde) followed by ethylene oxide

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-03-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611648 on ClinicalTrials.gov