Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT04967976

Breast Mesh Used in Two-staged Breast Reconstruction

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2021-07-20

300

Participants Needed

6

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Breast Mesh Used in Two-staged Breast Reconstruction

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with breast cancer
  • Age over 18 years and under 70 years
  • Karnofsky Performance Status larger than 80
  • No clinical or imaging evidence of distant metastasis
  • Body Mass Index under 35 kg/m2
  • Patients with no or mild breast ptosis
  • No severe problems in blood, heart, immune system, liver, or kidney function
  • Mental health patient
Not Eligible

You will not qualify if you...

  • Distant metastasis or local recurrence of breast cancer
  • Previous radiation to the same breast or chest wall
  • Inflammatory breast cancer or stage IV breast cancer
  • History of severe allergies or specific constitution
  • Mental illness
  • Drug or alcohol abuse
  • Pregnancy, breastfeeding, or becoming pregnant during the study
  • Not eligible based on researchers' judgment

AI-Screening

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Trial Site Locations

Total: 6 locations

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

2

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Actively Recruiting

3

Jilin Cancer Hospital

Ch’ang-ch’un, Jilin, China

Actively Recruiting

4

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

5

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

6

Technical University of Munich

Munich, Germany

Actively Recruiting

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Research Team

J

Jian Yin

CONTACT

B

Bowen Ding

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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