Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2021-08-01
2026-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Breast Reconstruction with breast mesh
The tissue expander-implant reconstruction with TiLoop Bra mesh.
TiLoop Bra mesh in expander-implant breast reconstrution
The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
Breast Reconstruction without breast mesh
The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
sub-pectoral expander-implant breast reconstruction
The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
Interventions
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TiLoop Bra mesh in expander-implant breast reconstrution
The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
sub-pectoral expander-implant breast reconstruction
The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
Eligibility Criteria
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Inclusion Criteria
2. More than 18 years old
3. Karnofsky Performance Status (KPS) larger than 80
4. No clinical or imaging evidence of distant metastasis
5. BMI \< 35kg/m2
6. Patients with no or mild breast ptosis
7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
8. Mental Health Patient
\-
Exclusion Criteria
\-
18 Years
70 Years
FEMALE
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Jilin Cancer Hospital
Ch’ang-ch’un, Jilin, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Technical University of Munich
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Edward Chang
Role: primary
Suisheng Yang
Role: primary
Guiying Xu
Role: primary
Xuli Meng
Role: primary
Stefan Paepke
Role: primary
Other Identifiers
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E20210210
Identifier Type: -
Identifier Source: org_study_id
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