Breast Cancer Clinical Trial

Breast Mesh Used in Two-staged Breast Reconstruction

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

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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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Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT04967976

Recruitment Status:

Recruiting

Sponsor:

Tianjin Medical University Cancer Institute and Hospital

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There are 2 Locations for this study

See Locations Near You

MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Edward Chang
Contact
Gansu Provincial Cancer Hospital
Lanzhou Gansu, , China More Info
Suisheng Yang
Contact
Jilin Cancer Hospital
Ch'ang-ch'un Jilin, , China More Info
Guiying Xu
Contact
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China More Info
Bowen Ding
Contact
18822077799
[email protected]
Jian Yin
Principal Investigator
Bowen Ding
Sub-Investigator
Zhejiang Provincial People's Hospital
Hangzhou Zhejiang, , China More Info
Xuli Meng
Contact
Technical University of Munich
Munich , , Germany More Info
Stefan Paepke
Contact

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT04967976

Recruitment Status:

Recruiting

Sponsor:


Tianjin Medical University Cancer Institute and Hospital

How clear is this clinincal trial information?

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