UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059732 |
|---|---|
| Receipt number | R000068311 |
| Scientific Title | Clinical evaluation of a device for preventing electrode rotation in intrathoracic adhesiolysis |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/10 22:04:41 |
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Basic information
Public title
Clinical evaluation of a device for preventing electrode rotation in intrathoracic adhesiolysis
Acronym
Electrode Rotation Prevention Device - Clinical Evaluation
Scientific Title
Clinical evaluation of a device for preventing electrode rotation in intrathoracic adhesiolysis
Scientific Title:Acronym
Clinical evaluation of a device for preventing electrode rotation in intrathoracic adhesiolysis
Region
| Japan |
Condition
Condition
Elective surgery cases necessitating lysis of intrathoracic adhesions
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the use of the newly developed device for preventing electrode rotation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the use of the newly developed device for preventing electrode rotation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elective surgical cases requiring lysis of dense intrathoracic adhesions.
Survey Participants: Thoracic surgeons (operating surgeons, including residents) who used the device.
Key exclusion criteria
Patients without dense intrathoracic adhesions
Patients who do not consent to participate in this study.
Patients aged under 20
Junior residents
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
St. Marianna University School of Medicine
Division name
Department of Thoracic Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
takahiro.homma@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Homma |
Organization
St. Marianna University School of Medicine
Division name
Department of Thoracic Surgery
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
takahiro.homma@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
Tel
044-977-8111
kenkyu@marianna-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 | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068311
