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ACTIVE NOT RECRUITING
NCT03589924
NA

Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)

Sponsor: Jiong Wu

View on ClinicalTrials.gov

Summary

This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.

Official title: A Randomized Multicenter, Open, Prospective, Controlled Study-comparison of the Safety of Immediate One-stage Implant Based Breast Reconstruction(IBBR) Versus Two-stage Expander-Implant IBBR Augmented With TiLoop® Bra.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

440

Start Date

2018-06-01

Completion Date

2024-09-30

Last Updated

2024-06-21

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Immediate IBBR+TiLoop®Bra

Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra

PROCEDURE

Immediate-delayed IBBR+TiLoop®Bra

Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra

Locations (11)

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Guangdong Women and Children Hospital

Guangzhou, Guangdong, China

Hebei Cancer Hospital

Shijiazhuang, Hebei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The first hospital of China medical university

Shengyang, Liaoning, China

Liaoning Cancer Hospital & Insitute

Shenyang, Liaoning, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Cancer Hospital/ Institute, Fudan University

Shanghai, Shanghai Municipality, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China