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

Sterility Clinical Trial

Official title:

Effectiveness of Nasal Endoscope Sterilization Using a Novel Rig-S™ Device: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605003
• Other study ID #: Novel rig-S
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: October 2020
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All rigid endoscopes performed in ORL clinic

Exclusion Criteria:

Flexible endoscopes performed in ORL clinic

Related Conditions & MeSH terms

• Infertility
• Sterility

Intervention

Device:
• Novel rig-S
A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
• Conventional Autoclave machine
The gold standard device to clean all medical instruments

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial and Hepatitis B test	Rigid endoscopes are swabbed and tested using a hep-B kit	3 days
Secondary	Acidity level	Acidity level of the high level disinfectant is tested for every 10 cycles of scope	4 hours