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CompletedNCT04039906Updated Dec 3, 2019

A Single-institutional Study to Assess the Time Efficiency and Working Satisfaction Using ANDY(Automatic Needle Destroyer)

An interventional study of Removal of needle with using ANDYs in Needle Stick Injuries, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety when using ANDY(Automatic Needle Destroyer). Install ANDY(Automatic Needle Destroyer) in the ER, and evaluate the system by comparing the efficiency of the work, usability, actual decrease ratio of needlestick injury between using the automated needle processing system and not using it.

Read the detailed description
  1. Background The most frequent occupational injury is exposure to blood and fluid by needlestick injury. Needlestick injuries can result in serious infections if appropriate infection control measures are not taken promptly.

    Since the use of safety devices are not popularly used, the needle and syringe are mostly taken into pieces by physical ways. There are some cases that the needle and syringe is not separated, and the entire syringe can be put directly into the waste container. There is also a problem that it takes a lot of time and efforts to remove needles from syringes. In addition, the existing safety mechanism is physical methods such as pulling out the needle, damaging or cutting the needle, or using heat to the needle, or melting it by using chemicals. It is a semi-manual since you have to wait holding the syringe during the process, and it is inconvenient to use considering a busy medical environment.

    Therefore, we developed ANDY(Automatic Needle Destroyer) that can be introduced at a convenient and reasonable cost, and try to objectively evaluate the utility of ANDY in a clinical environment.

  2. Purpose The purpose of this study is to Evaluate the efficiency of adopting the automated needle processing system by evaluating efficiency, usability and safety of the system.
  3. Design : RCT (randomized controlled trial)
  4. Setting: EMERGENCY CENTER at the Samsung Medical Center
  5. Enrollment : 129 medical staffs in the ER. 10ea ANDY and 10ea of Existing waste containers(needle box)
  6. Intervention :

    6-1) 1st Week : Removal of needle with existing method

    • Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
    • Identify the number of syringes processed by existing method.
    • Do survey after 1st week

    6-2) 2nd week: Prepare for using ANDYs

    • Provide clinicians with instruction how to use ANDY
    • Install 10 ANDYs in the ER.

    6-3) 3rd week : Removal of needle with using ANDYs

    • Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
    • Identify the number of syringes processed by ANDY.
    • After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees feel those are necessary.
  7. Scoring: By the answers of the Questionnaire of Satisfaction (SUS and adjective score)
  8. Study period : 3 weeks
  9. Satisfaction survey: SUS and adjective score
02

Conditions studied

  • Needle Stick Injuries

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Keywords

  • Efficiency,Usability,Safety
03

In context

Needlestick Injuries

30 studies on the registry are indexed under Needlestick Injuries; 3 are open to participants now.

This study's enrollment of 129 is above the median of 67 across 25 interventional studies indexed under Needlestick Injuries.

Browse Needlestick Injuries studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • medical staff of the ER
  • adult ER medical staff over 19 years of age
  • A subject who voluntarily agrees and signs

Exclusion criteria

Exclusion Criteria:

•A subject who did not agree with this study

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • No intervention
    Removal of needle with existing method

    Participants will remove needles from syringes with the existing method like they are already doing. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)

  • Experimental
    Removal of needle with using ANDYs

    Participants will remove needles from syringes with Andy. (Record the time required for the needle removal procedure by photographing during 24 hours/7 days.)

    Device: Removal of needle with using ANDYs

Interventions

  • DeviceRemoval of needle with using ANDYs

    1. ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days 2. Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days. Identify the number of syringes processed by ANDY. 3. After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees felt those are necessary.

06

What researchers measure

Primary outcomes

  1. Time Efficiency: Comparing the time required to remove the needle from syringe for assessing change in time between using automated needle processing system or not

    - Comparison of the required time(second) to remove the needle between using the automated needle processing system and not using it.

    Time frame: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)

Secondary outcomes

  1. Usability: Comparing the SUS score for assessing the change in usability between using automated needle processing system or not

    - Comparison of the usability between using the automated needle processing system and not using it by doing survey after 1st week and 3rd week and Interview after 3rd week( Scoring by the answers of the Questionnaire of Satisfaction (SUS) and adjective score)

    Time frame: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)

  2. Safety: Comparing the number of accidents of the needlestick injuries between using automated needle processing system or not

    - Comparison of the number of accidents of the needlestick injuries between using the automated needle processing system and not using it.

    Time frame: [1st Week] : Removal of needle in accordance with existing method, [3rd week] : using a ANDY(automated needle processing system)

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04039906
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Jul 31, 2019
Start date
Sep 2, 2019
Primary completion
Sep 23, 2019
Completion
Sep 23, 2019
Last update
Dec 3, 2019

Study contacts

TAERIM KIM, Doctoral
principal investigator · Samsung Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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