UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058236 |
|---|---|
| Receipt number | R000066509 |
| Scientific Title | A non-randomized, open-label, single-center, exploratory study comparing the time required for flap creation in video-assisted thyroid surgery using conventional muscle hooks versus a cordless LED illuminated transparent plastic hook (Koplight S) |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/20 13:09:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A non-randomized, open-label, single-center, exploratory study comparing the time required for flap creation in video-assisted thyroid surgery using conventional muscle hooks versus a cordless LED illuminated transparent plastic hook (Koplight S)
Acronym
VANS-Koplight S trial
Scientific Title
A non-randomized, open-label, single-center, exploratory study comparing the time required for flap creation in video-assisted thyroid surgery using conventional muscle hooks versus a cordless LED illuminated transparent plastic hook (Koplight S)
Scientific Title:Acronym
VANS-Koplight S trial
Region
| Japan |
Condition
Condition
Graves' disease, Thyroid tumor, Parathyroid disease
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratively examine whether the use of the cordless LED illuminated transparent plastic hook, Koplight S, during flap creation in Video-Assisted Neck Surgery (VANS) can reduce the time required for flap creation compared to the use of conventional retractor hooks (conventional retractor hooks group) in patients undergoing VANS. Additionally, the study will exploratively investigate the safety by comparing the number of bleeding occurrences during the dissection process of flap creation between the two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Time required for flap creation (time from the start of surgery to the completion of flap creation
Key secondary outcomes
Number of bleeding occurrences during the dissection process of flap creation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conventional retractor hook group: Using the conventional retractor hook during flap creation in video-assisted neck surgery (VANS).
Interventions/Control_2
Koplight S group: Using the cordless LED-illuminated transparent plastic hook, Koplight S, during flap creation in video-assisted neck surgery (VANS).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1. Female patients who have undergone or are scheduled to undergo VANS for Graves' disease, thyroid tumors, or parathyroid disorders
-Conventional retractor hook group: Patients who underwent VANS between January 1, 2024, and March 31, 2025
-Koplight S group: Patients scheduled to undergo VANS between the approval date by the head of the research institution and March 31, 2026
2. Patients aged 20 to 69 years
3. Patients with a BMI of less than 30
Key exclusion criteria
Patients who are determined by the principal investigator or study collaborators to be inappropriate for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nanashima |
Organization
University of Miyazaki Faculty of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
0985-85-2808
a_nanashima@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Higuchi |
Organization
University of Miyazaki Faculty of Medicine
Division name
Division of the Gastrointestinal, Endocrine and Pediatric Surgery
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki
TEL
0985-85-2808
Homepage URL
kazuhiro_higuchi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, University of Miyazaki
Address
5200, Kiyotakecho-Kihara, Miyazaki, Miyazaki
Tel
0985-85-9403
rinken@med.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066509
