UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057331 |
|---|---|
| Receipt number | R000065533 |
| Scientific Title | A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets |
| Date of disclosure of the study information | 2025/03/18 |
| Last modified on | 2025/03/18 17:41:04 |
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Basic information
Public title
A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets
Acronym
A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets
Scientific Title
A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets
Scientific Title:Acronym
A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of the sling method using the Neover sheet at the time of tissue expanders insertion, and to evaluate the safety and efficacy of subcutaneous and partial subcutaneous insertion of tissue expanders without increasing the risk of postoperative complications.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue expanders extraction rate within 6 months after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Patients with a subcutaneous tissue thickness of at least 1 cm, no problems with breast skin blood flow on intraoperative ICG examination, and no plans for postoperative radiation therapy will be included. In indicated cases, subcutaneous TE insertion will be performed with the TE covered with Neoveil sheets without subpectoral dissection.
Interventions/Control_2
Patients with a subcutaneous tissue thickness of 0.5 to 1 cm, with no problems with blood flow in the breast skin on intraoperative ICG examination, and with no plans for postoperative radiation therapy are eligible for this procedure. A subpectoral dissection is performed, and at the caudal margin, the pectoralis major muscle attachment is dissected; the TE is inserted under the dissected pectoralis major muscle, and the lateral and caudal portions are covered with a Neover Sheet. The anterior sheath and anterior serratus fascia are not dissected under the anterior sheath and anterior serratus fascia as in the conventional subthoracic insertion technique.
Interventions/Control_3
Patients with breast skin less than 0.5 mm or with problems with breast skin blood flow, complicated pectoralis major muscle excision at the time of mastectomy, or with large breast size that makes complete coverage by the pectoralis major muscle difficult.Attach and fix the Neover Sheet in a patch-like fashion to the area where the TE could not be covered by the pectoralis major muscle, and close the defect.
Interventions/Control_4
Patients with previous infection/irradiation and reoperation cases are targeted for TE insertion subcutaneously with the TE covered with a Neoverl sheet. If it is determined from the breast skin condition that better morphology can be obtained by inserting the TE in a rotated position, insert the TE in a rotated position. Autologous tissue reconstruction is performed within 3 months after TE insertion.
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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
Adult female patients
Patients with primary breast cancer who are scheduled to undergo TE insertion and whose breast skin thickness after breast cancer resection is 0.5 mm or more and who have no skin blood flow problem, and patients whose breast is less than 0.5 mm or who have breast skin blood flow problem but for whom full TE coverage with pectoralis major muscle is difficult, or who have a history of infection, radiation, or breast surgery Patients who have a history of infection, irradiation, or breast surgery and are scheduled to undergo TE insertion for breast reconstruction in the future.
Patients who have received a full explanation of the study based on the same document and who have fully understood it, and who have given their consent to participate in the study of their own free will.
Key exclusion criteria
Patients receiving steroids or immunosuppressive drugs for other diseases on a continuous basis
Patients with poorly controlled diabetes mellitus
Smokers
Obesity patients with a BMI of 25 or more
Other patients whom the investigator deems inappropriate to participate in the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Satake |
Organization
Toyama University Hospital
Division name
Plastic Reconstructive and Aesthetic Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture
TEL
0764342315
toshi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kahori |
| Middle name | |
| Last name | Tsukura |
Organization
Toyama University Hospital
Division name
Plastic Reconstructive and Aesthetic Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture
TEL
0764342315
Homepage URL
ktsukura73tyrd@gmail.com
Sponsor or person
Institute
Toyama University
Institute
Department
Personal name
Funding Source
Organization
Toyama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyama University Hospital
Address
2630 Sugitani, Toyama City, Toyama Prefecture
Tel
0764342315
ktsukura73tyrd@gmail.com
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 | 03 | Month | 18 | 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 | 03 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065533
