Using TiLOOP Bra mesh in breast reconstruction after cancer
A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
NA · Tianjin Medical University Cancer Institute and Hospital · NCT04967976
This study is testing if using TiLOOP® Bra mesh during breast reconstruction after cancer can help improve recovery and results for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 6 sites (Houston, Texas and 5 other locations) |
| Trial ID | NCT04967976 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of TiLOOP® Bra mesh in patients undergoing expander-implant breast reconstruction following a breast cancer diagnosis. It is a prospective randomized controlled study aimed at evaluating the efficacy and safety of the mesh, with the hypothesis that it will reduce capsular contraction rates, enhance the efficiency of tissue expansion, and improve aesthetic outcomes. Participants will be monitored for their recovery and the overall success of the reconstruction process.
Who should consider this trial
Good fit: Ideal candidates are adult women diagnosed with breast cancer who meet specific health criteria and have no severe comorbidities.
Not a fit: Patients with advanced breast cancer, prior radiation to the breast, or significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and patient satisfaction in breast reconstruction after cancer.
How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promising results with mesh use in other reconstructive surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with breast cancer 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: 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 \-
Where this trial is running
Houston, Texas and 5 other locations
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (RECRUITING)
- Jilin Cancer Hospital — Ch’ang-ch’un, Jilin, China (RECRUITING)
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (RECRUITING)
- Technical University of Munich — Munich, Germany (RECRUITING)
Study contacts
- Study coordinator: Jian Yin
- Email: yinjian@tjmuch.com
- Phone: +86-22-23340123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Radiation, Breast Reconstruction, Synthetic Mesh, breast cancer, breast reconstruction, radiation, synthetic mesh