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

NCT03589924 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2024-06-21

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • First Hospital of China Medical University

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Jiong Wu

    lead OTHER

Principal Investigators

  • Jiong Wu, M.D. · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2023-04-30
Completion
2024-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03589924 on ClinicalTrials.gov