UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056544 |
|---|---|
| Receipt number | R000064606 |
| Scientific Title | The role of laser interstitial coagulation in vacuum aspiration biopsy and resection of breast tumors |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2024/12/23 21:39:43 |
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Basic information
Public title
The role of laser interstitial coagulation in vacuum aspiration biopsy and resection of breast tumors
Acronym
Laser interstitial coagulation during vacuum aspiration biopsy of the breast
Scientific Title
The role of laser interstitial coagulation in vacuum aspiration biopsy and resection of breast tumors
Scientific Title:Acronym
Laser interstitial coagulation during vacuum aspiration biopsy of the breast
Region
| Europe |
Condition
Condition
benign neoplasms of breast
Classification by specialty
| Breast surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of LIC in VAB for therapeutic purposes in patients with single and multiple breast tumors; to describe the criteria for the effectiveness and sufficiency of LIC in VAB with intraoperative navigation in real time.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction of the frequency of hemorrhagic complications in the postoperative period
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Vacuum aspiration biopsy and laser interstitial coagulation hemostasis/ultrasound control of hemorrhagic complications
Interventions/Control_2
Vacuum aspiration biopsy and medicamentous combined with compression hemostasis/ultrasound control of hemorrhagic complications
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
the presence of indications for VAB for diagnostic and therapeutic-diagnostic purposes in accordance with the national clinical recommendations, taking into account the procedure and standards for providing medical care according to the disease profile
Key exclusion criteria
cytologically/histologically confirmed malignant nature of breast neoplasms.
Target sample size
172
Research contact person
Name of lead principal investigator
| 1st name | Anatoly |
| Middle name | Vasilievich |
| Last name | Levanov |
Organization
Federal State Budgetary Scientific Institution Petrovsky National Research Centre of Surgery
Division name
Scientific and Clinical Center No. 2
Zip code
119333
Address
Russia, Moscow, st. Fotieva, 10
TEL
+7926221097
lavina2003@inbox.ru
Public contact
Name of contact person
| 1st name | Anatoly |
| Middle name | Vasilievich |
| Last name | Levanov |
Organization
Federal State Budgetary Scientific Institution Petrovsky National Research Centre of Surgery
Division name
Scientific and Clinical Center No. 2
Zip code
119333
Address
Russia, Moscow, st. Fotieva, 10
TEL
+7926221097
Homepage URL
lavina2003@inbox.ru
Sponsor or person
Institute
Federal State Budgetary Scientific Institution Petrovsky National Research Centre of Surgery
Institute
Department
Personal name
Funding Source
Organization
Federal State Budgetary Scientific Institution Petrovsky National Research Centre of Surgery
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
Federal State Budgetary Scientific Institution Petrovsky National Research Centre of Surgery
Address
Moscow, Abrikosovsky st, 2
Tel
+7 (499) 248-15-55.
nrcs@med.ru
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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://cyberleninka.ru/article/n/ispolzovanie-lazernogo-interstitsialnogo-izlucheniya-dlya-koagulya
Number of participants that the trial has enrolled
172
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064606
