NCT04605003

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

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

Study Start

First participant enrolled

October 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 27, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

October 16, 2020

Last Update Submit

October 25, 2020

Conditions

Sterility

Outcome Measures

Primary Outcomes (1)

  • Microbial and Hepatitis B test

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

    3 days

Secondary Outcomes (1)

  • Acidity level

    4 hours

Study Arms (2)

Conventional Autoclave

ACTIVE COMPARATOR

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

Device: Novel rig-SDevice: Conventional Autoclave machine

Novel rig-S

ACTIVE COMPARATOR

A novel devise used with the high level disinfectant

Device: Novel rig-SDevice: Conventional Autoclave machine

Interventions

Novel rig-SDEVICE

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

Conventional AutoclaveNovel rig-S
Conventional Autoclave machineDEVICE

The gold standard device to clean all medical instruments

Conventional AutoclaveNovel rig-S

Eligibility Criteria

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

You may qualify if:

  • All rigid endoscopes performed in ORL clinic

You may not qualify if:

  • Flexible endoscopes performed in ORL clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Salina Husain, MMED

    Universiti Kebangsaan Malaysia Medical Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The swabbing of the endoscopes are performed by a research assistant, and the end result is evaluated by the primary investigator
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 27, 2020

Study Start

October 1, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

MY(1)