Post-Surgical Contamination of Rigid Endoscopic InstrumentsNCT07077499
Cleaning Efficacy of Pulsed Vacuum Device on Rigid Endoscopic Instruments
A study testing Pulsed Vacuum Cleaning and Disinfection Device and Vacuum Ultrasonic Cleaner in people with Post-Surgical Contamination of Rigid Endoscopic Instruments, run by Xue Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-Surgical Contamination of Rigid Endoscopic Instruments
- What is being tested?
- Pulsed Vacuum Cleaning and Disinfection Device and Vacuum Ultrasonic Cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Rigid endoscopic instruments scheduled for post-operative cleaning.
- Types of instruments included: laparoscopes, hysteroscopes, arthroscopes, nephroscopes, prostate resection scopes, and thoracoscopes.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Shijiazhuang Maternal and Child Health Hospital
Shijiazhuang, Hebei, 050000
About this study
Official title: Analysis of the Cleaning Effect of Pulsed Vacuum Cleaning and Disinfection Device on Rigid Endoscopic Instruments
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.
Read the detailed description
Rigid endoscopic instruments, due to their complex structure, pose significant challenges for cleaning and sterilization, which is critical for preventing hospital-acquired infections. Traditional methods like ultrasonic and spray cleaning have limitations in efficiency and thoroughness. This study was conducted to assess a newer technology, the pulsed vacuum cleaning and disinfection device, which integrates cleaning, rinsing, disinfection, and drying. A total of 800 rigid endoscopic instruments were divided into two groups: one cleaned with the pulsed vacuum device (Observation Group) and the other with a conventional vacuum ultrasonic cleaner (Control Group). The study aims to provide evidence-based insights into the efficiency, efficacy, and safety of the pulsed vacuum device for clinical application in sterilization supply centers.
- Being tested
- Pulsed Vacuum Cleaning and Disinfection Device, Vacuum Ultrasonic Cleaner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Vacuum Cleaning and Disinfection DeviceDevice
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.
Vacuum Ultrasonic CleanerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Vacuum Cleaning Group | Experimental | A total of 400 rigid endoscopic instruments were cleaned using a pulsed vacuum cleaning and disinfection device following manual pre-treatment. The process integrated cleaning, rinsing, disinfection, and vacuum drying into a single automated cycle. Receives: Device: Pulsed Vacuum Cleaning and Disinfection Device |
| Ultrasonic Cleaning Group | Active comparator | A total of 400 rigid endoscopic instruments were cleaned using a conventional vacuum ultrasonic cleaner, followed by a separate spray cleaning and drying process, after manual pre-treatment. Receives: Device: Vacuum Ultrasonic Cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein Residue Detection
The level of residual protein on the instrument surface was measured using the biuret method. Outcomes were categorized as clean, mild, moderate, or severe contamination. The rate of clean instruments was compared between groups.
Measured: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
Cleaning Qualification Rate
The cleaning effect was evaluated based on the "Hospital Sterilization Supply Center Part 3: Cleaning, Disinfection, and Sterilization Effect Monitoring Standards". Qualification was determined by a composite of three methods:
- Visual Inspection: No visible contaminants.
- Magnifying Light Source Observation: No visible stains or residues under magnification.
- ATP Fluorescence Detection: Relative Light Unit (RLU) value ≤2000. The percentage of instruments passing all three checks was calculated.
Measured: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
Secondary outcomes (2)
Cleaning Time
Total time required to process all 400 instruments in each group, from the start of manual pre-treatment to the completion of the final drying step. Unit: Minutes.
Measured: Assessed during a single time point event (the cleaning procedure on Day 0). The duration of the measurement is approximately 60 to 90 minutes.
Instrument Damage Rate
The number and percentage of instruments found to be damaged (e.g., deformation, breakage) after the complete cleaning and drying cycle in each group.
Measured: Assessed at a single time point: immediately after the completion of the single cleaning procedure on Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Surgical Contamination of Rigid Endoscopic InstrumentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xue Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xue Wang, Shijiazhuang Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077499
- Sponsor's protocol ID
- 2024039
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Cleaning Effect of Pulsed Vacuum Cleaning and Disinfection Device on Rigid Endoscopic Instruments
- ClinicalTrials.gov ID
- NCT07077499
- Acronym / sponsor ID
- 2024039
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Xue WangUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rigid endoscopic instruments, due to their complex structure, pose significant challenges for cleaning and sterilization, which is critical for preventing hospital-acquired infections. Traditional methods like ultrasonic and spray cleaning have limitations in efficiency and thoroughness. This study was conducted to assess a newer technology, the pulsed vacuum cleaning and disinfection device, which integrates cleaning, rinsing, disinfection, and drying. A total of 800 rigid endoscopic instruments were divided into two groups: one cleaned with the pulsed vacuum device (Observation Group) and the other with a conventional vacuum ultrasonic cleaner (Control Group). The study aims to provide evidence-based insights into the efficiency, efficacy, and safety of the pulsed vacuum device for clinical application in sterilization supply centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Vacuum Cleaning Group | Experimental | Device: Pulsed Vacuum Cleaning and Disinfection DeviceA total of 400 rigid endoscopic instruments were cleaned using a pulsed vacuum cleaning and disinfection device following manual pre-treatment. The process integrated cleaning, rinsing, disinfection, and vacuum drying into a single automated cycle. |
| Ultrasonic Cleaning Group | Active comparator | Device: Vacuum Ultrasonic CleanerA total of 400 rigid endoscopic instruments were cleaned using a conventional vacuum ultrasonic cleaner, followed by a separate spray cleaning and drying process, after manual pre-treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Rigid endoscopic instruments scheduled for post-operative cleaning.
- Types of instruments included: laparoscopes, hysteroscopes, arthroscopes, nephroscopes, prostate resection scopes, and thoracoscopes.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Vacuum Cleaning and Disinfection DeviceAfter 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 | Pulsed Vacuum Cleaning Group |
| Vacuum Ultrasonic CleanerAfter 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. | Device | Ultrasonic Cleaning Group |
Primary outcome
Protein Residue Detection
Time frame: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
The level of residual protein on the instrument surface was measured using the biuret method. Outcomes were categorized as clean, mild, moderate, or severe contamination. The rate of clean instruments was compared between groups.
Cleaning Qualification Rate
Time frame: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
The cleaning effect was evaluated based on the "Hospital Sterilization Supply Center Part 3: Cleaning, Disinfection, and Sterilization Effect Monitoring Standards". Qualification was determined by a composite of three methods: * Visual Inspection: No visible contaminants. * Magnifying Light Source Observation: No visible stains or residues under magnification. * ATP Fluorescence Detection: Relative Light Unit (RLU) value ≤2000. The percentage of instruments passing all three checks was calculated.
2 secondary outcomes
Cleaning Time
Time frame: Assessed during a single time point event (the cleaning procedure on Day 0). The duration of the measurement is approximately 60 to 90 minutes.
Instrument Damage Rate
Time frame: Assessed at a single time point: immediately after the completion of the single cleaning procedure on Day 0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Vacuum Cleaning and Disinfection Device and Vacuum Ultrasonic Cleaner in people with Post-Surgical Contamination of Rigid Endoscopic Instruments, run by Xue Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein Residue Detection (time frame: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.