Status Unknown
A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2021-07-20
300
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.
CONDITIONS
Brief Title
Breast Mesh Used in Two-staged Breast Reconstruction
Who Can Participate
Eligibility Criteria
Inclusion Criteria:
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Diagnosed with breast cancer
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More than 18 years old
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Karnofsky Performance Status (KPS) larger than 80
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No clinical or imaging evidence of distant metastasis
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BMI < 35kg/m2
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Patients with no or mild breast ptosis
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No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
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Mental Health Patient
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Exclusion Criteria:
1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion
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Research Team
J
Jian Yin
B
Bowen Ding
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