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Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device

Primary Purpose

Sterility

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Novel rig-S
Conventional Autoclave machine
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sterility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All rigid endoscopes performed in ORL clinic

Exclusion Criteria:

Flexible endoscopes performed in ORL clinic

Sites / Locations

  • Universiti Kebangsaan Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Autoclave

Novel rig-S

Arm Description

The conventional autoclave is the gold standard of sterilising all medical equipments.

A novel devise used with the high level disinfectant

Outcomes

Primary Outcome Measures

Microbial and Hepatitis B test
Rigid endoscopes are swabbed and tested using a hep-B kit

Secondary Outcome Measures

Acidity level
Acidity level of the high level disinfectant is tested for every 10 cycles of scope

Full Information

First Posted
October 16, 2020
Last Updated
October 25, 2020
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04605003
Brief Title
Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device
Official Title
Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the sterility of rigid nasoendoscopies after being sterilized with a conventional autoclave machine and a novel rig-S device that uses standard high level disinfectant
Detailed Description
There is a standard operating procedure in rigid endoscopy cleaning, and it is performed after each clinical examination. The conventional autoclave is no longer used in the setting of an otorhinolaryngology (ORL) clinic as it is cumbersome and takes a lot of time, and also only cleans one endoscope at a time. There is no standardisation or device that has been reported, and cross contamination has been reported previously. The overturn of patients in the ORL clinic is high, and most practitioners chooses high level disinfectant as a method of sterilising the endoscopes. However, there is no proper device to place these disinfectants in, and results in many cases of broken scopes and cross contamination. This study compares the sterility of the rigid endoscopes after being sterilised by the high level disinfectant that is placed in a novel rig-S device with the gold standard conventional autoclave. The investigators selected all the rigid endoscopes performed in our ORL clinic and randomised them before subjecting them for a swab test for bacterial and fungal, and also used a test kit to test the presence of Hepatitis B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The swabbing of the endoscopes are performed by a research assistant, and the end result is evaluated by the primary investigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Autoclave
Arm Type
Active Comparator
Arm Description
The conventional autoclave is the gold standard of sterilising all medical equipments.
Arm Title
Novel rig-S
Arm Type
Active Comparator
Arm Description
A novel devise used with the high level disinfectant
Intervention Type
Device
Intervention Name(s)
Novel rig-S
Intervention Description
A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
Intervention Type
Device
Intervention Name(s)
Conventional Autoclave machine
Intervention Description
The gold standard device to clean all medical instruments
Primary Outcome Measure Information:
Title
Microbial and Hepatitis B test
Description
Rigid endoscopes are swabbed and tested using a hep-B kit
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Acidity level
Description
Acidity level of the high level disinfectant is tested for every 10 cycles of scope
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All rigid endoscopes performed in ORL clinic Exclusion Criteria: Flexible endoscopes performed in ORL clinic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salina Husain, MMED
Organizational Affiliation
Universiti Kebangsaan Malaysia Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia

12. IPD Sharing Statement

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Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device

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