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Completed

NCT Number: NCT04605003

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

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

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Key information

Conditions

Sterility Genital Diseases Infertility Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All rigid endoscopes performed in ORL clinic

Exclusion criteria

Flexible endoscopes performed in ORL clinic

Treatment and study plan

Novel rig-S

Device

A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed

Conventional Autoclave machine

Device

The gold standard device to clean all medical instruments

Primary outcomes

  1. Microbial and Hepatitis B test

    Time frame: 3 days

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

Secondary outcomes

  1. Acidity level

    Time frame: 4 hours

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

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2020
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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