CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 440 enrolled
Drug / intervention
Immediate IBBR+TiLoop®Bra +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03589924
NCT03589924N/AActive
CompareCT.gov

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.

Jiong Wu·interventional·Posted Jul 18, 2018·Updated Jun 21, 2024

In Brief

A clinical study evaluating Immediate IBBR+TiLoop®Bra and Immediate-delayed IBBR+TiLoop®Bra for Breast Cancer. Active but no longer recruiting, targeting 440 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
CollaboratorsFirst Hospital of China Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, The First Affiliated Hospital with Nanjing Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Timeline

N/AActiveOverdue
20192020202120222023202420252026
First PostedJul 18, 2018
Enrollment StartJun 1, 2018
Primary CompletionApr 30, 2023
Study CompletionSep 30, 2024
TodayJul 1, 2026
Enrollment to primary: 4.9 yearsPosted 8.0 years ago

Interventions

Immediate IBBR+TiLoop®Braprocedure

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

Immediate-delayed IBBR+TiLoop®Braprocedure

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