NCT04967976 Breast Mesh Used in Two-staged Breast Reconstruction
| NCT ID | NCT04967976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2023-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-08-01 with a primary completion date of 2023-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04967976 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04967976 currently recruiting?
Yes, NCT04967976 is actively recruiting participants. Contact the research team at yinjian@tjmuch.com for enrollment information.
Where is the NCT04967976 trial being conducted?
This trial is being conducted at Houston, United States, Lanzhou, China, Ch’ang-ch’un, China, Tianjin, China and 2 additional locations.
Who is sponsoring the NCT04967976 clinical trial?
NCT04967976 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 300 participants.
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