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Mesh Implant

Mesh Use in Two-Stage Breast Reconstruction

N/A
Recruiting
Research Sponsored by Tianjin Medical University Cancer Institute and Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with breast cancer
No clinical or imaging evidence of distant metastasis
Must not have
Inflammatory breast cancer, stage IV breast cancer
Patients with distant metastasis of breast cancer or local recurrence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Summary

This trial looks at whether using a TiLOOP Bra mesh with tissue expanders reduces rates of capsular contraction, improves efficiency of expansion, and provides better aesthetic results.

Who is the study for?
This trial is for breast cancer patients with a BMI under 35, no distant metastasis, good performance status (KPS > 80), minimal breast sagging, and over 18 years old. They must have normal organ function and mental health. Excluded are those with mental illness, pregnant or breastfeeding women, past chest radiation, stage IV cancer or severe allergies.Check my eligibility
What is being tested?
The study tests the effectiveness of TiLOOP Bra mesh in two-stage expander-implant breast reconstruction compared to standard sub-pectoral methods. It aims to see if this mesh can reduce complications like capsular contraction and improve aesthetic outcomes.See study design
What are the potential side effects?
Potential side effects may include local reactions at the surgery site such as pain, infection risk increase due to implantation of foreign material (mesh), possible allergic reactions to the mesh material itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with breast cancer.
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My cancer has not spread to distant parts of my body.
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I am mostly self-sufficient and active.
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I am older than 18 years.
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My blood, heart, immune system, liver, and kidneys are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer is inflammatory or at stage IV.
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My breast cancer has spread to distant parts of my body or has come back in the same area.
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I have had radiation therapy on the same side of my chest before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complication Rates
Expansion Efficiency
Secondary outcome measures
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
number of occurrence of deep venous thrombosis
number of occurrence of non-surgical site infection
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Breast Reconstruction with breast meshExperimental Treatment1 Intervention
The tissue expander-implant reconstruction with TiLoop Bra mesh.
Group II: Breast Reconstruction without breast meshActive Control1 Intervention
The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

Find a Location

Who is running the clinical trial?

Tianjin Medical University Cancer Institute and HospitalLead Sponsor
367 Previous Clinical Trials
172,783 Total Patients Enrolled
1 Trials studying Breast Reconstruction
10,000 Patients Enrolled for Breast Reconstruction

Media Library

TiLOOP Bra mesh (Mesh Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04967976 — N/A
Breast Reconstruction Research Study Groups: Breast Reconstruction with breast mesh, Breast Reconstruction without breast mesh
Breast Reconstruction Clinical Trial 2023: TiLOOP Bra mesh Highlights & Side Effects. Trial Name: NCT04967976 — N/A
TiLOOP Bra mesh (Mesh Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04967976 — N/A
~77 spots leftby Jul 2025
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