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NCT04967976 | RECRUITING | Breast Cancer

Breast Mesh Used in Two-staged Breast Reconstruction
Sponsor:

Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease

Breast Cancer

Radiation

Breast Reconstruction

Synthetic Mesh

Intervention/treatment

TiLoop Bra mesh in expander-implant breast reconstrution

sub-pectoral expander-implant breast reconstruction

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
Actual Study Start Date : 2021-08-01
Estimated Primary Completion Date : 2023-08-01
Estimated Study Completion Date : 2026-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
    • -
Breast Mesh Used in Two-staged Breast Reconstruction

Location Details

NCT04967976

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

China, Gansu

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China,

RECRUITING

China, Jilin

Jilin Cancer Hospital

Ch'Ac-ch'un, Jilin, China,

RECRUITING

China, Tianjin

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin, China, 300060

RECRUITING

China, Zhejiang

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China,

RECRUITING

Germany,

Technical University of Munich

Munich, Germany,