Breast Mesh Used in Two-staged Breast Reconstruction
Status unconfirmed · Not applicable
Conditions studied: Breast Cancer, Radiation, Breast Reconstruction, Synthetic Mesh
In brief
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.
Key facts
- Study ID
- NCT04967976
- Run by
- Tianjin Medical University Cancer Institute and Hospital
- People needed
- 300
- Starts
- 2021-08-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2021-07-20
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with breast cancer
- More than 18 years old
- Karnofsky Performance Status (KPS) larger than 80
- No clinical or imaging evidence of distant metastasis
- BMI < 35kg/m2
- Patients with no or mild breast ptosis
- No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
- Mental Health Patient
You may not qualify if…
- 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
Where it is running
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (enrolling)
- Jilin Cancer Hospital — Ch’ang-ch’un, Jilin, China (enrolling)
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (enrolling)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
- Technical University of Munich — Munich, Germany (enrolling)
Full record on ClinicalTrials.gov
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