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Cleaning Efficacy of Pulsed Vacuum Device on Rigid Endoscopic Instruments

NCT07077499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-07-22

No results posted yet for this study

Summary

This study is a prospective, comparative trial designed to evaluate the cleaning effectiveness of a novel pulsed vacuum cleaning and disinfection device against a conventional vacuum ultrasonic cleaner for rigid endoscopic instruments. Key outcomes measured include cleaning time, cleaning quality (via visual, light source, and ATP inspection), protein residue levels, and instrument damage rate.

Conditions

  • Post-Surgical Contamination of Rigid Endoscopic Instruments

Interventions

DEVICE

Pulsed Vacuum Cleaning and Disinfection Device

After manual pre-treatment, instruments were placed into the pulsed vacuum cleaning and disinfection machine (Shandong Xinhua Medical, Model PC-150L). The automated program included pulsed vacuum cleaning, rinsing, thermal disinfection (93°C for 2.5 minutes), and vacuum drying.

DEVICE

Vacuum Ultrasonic Cleaner

After manual pre-treatment, instruments were cleaned in a vacuum ultrasonic cleaner (Shandong Xinhua Medical, Model super-6000) with a multi-enzyme solution for a minimum of 5 minutes. This was followed by a separate process in a spray cleaning and disinfection machine for rinsing and drying.

Sponsors & Collaborators

  • Xue Wang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT07077499 on ClinicalTrials.gov