A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
• \-
Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
China
Jilin Cancer Hospital
RECRUITING
Ch’ang-ch’un
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Gansu Provincial Cancer Hospital
RECRUITING
Lanzhou
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Germany
Technical University of Munich
RECRUITING
Munich
Contact Information
Primary
Jian Yin
yinjian@tjmuch.com
+86-22-23340123
Backup
Bowen Ding
ding_x87@126.com
+86-22-23340123
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 300
Treatments
Experimental: Breast Reconstruction with breast mesh
The tissue expander-implant reconstruction with TiLoop Bra mesh.
Active_comparator: Breast Reconstruction without breast mesh
The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital