Actively Recruiting
Breast Mesh Used in Two-staged Breast Reconstruction
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2021-07-20
300
Participants Needed
6
Research Sites
260 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
Official Title
Breast Mesh Used in Two-staged Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with breast cancer
- Age over 18 years and under 70 years
- Karnofsky Performance Status larger than 80
- No clinical or imaging evidence of distant metastasis
- Body Mass Index under 35 kg/m2
- Patients with no or mild breast ptosis
- No severe problems in blood, heart, immune system, liver, or kidney function
- Mental health patient
You will not qualify if you...
- Distant metastasis or local recurrence of breast cancer
- Previous radiation to the same breast or chest wall
- Inflammatory breast cancer or stage IV breast cancer
- History of severe allergies or specific constitution
- Mental illness
- Drug or alcohol abuse
- Pregnancy, breastfeeding, or becoming pregnant during the study
- Not eligible based on researchers' judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Actively Recruiting
3
Jilin Cancer Hospital
Ch’ang-ch’un, Jilin, China
Actively Recruiting
4
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
5
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
6
Technical University of Munich
Munich, Germany
Actively Recruiting
Research Team
J
Jian Yin
CONTACT
B
Bowen Ding
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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