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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.
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.
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 belowSelect...
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:Select...
My breast cancer is inflammatory or at stage IV.
Select...
My breast cancer has spread to distant parts of my body or has come back in the same area.
Select...
I have had radiation therapy on the same side of my chest before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complication Rates
Expansion Efficiency
Secondary study objectives
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 moreTrial 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
386 Previous Clinical Trials
177,534 Total Patients Enrolled
1 Trials studying Breast Reconstruction
10,000 Patients Enrolled for Breast Reconstruction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is inflammatory or at stage IV.You have a history of severe allergies or specific health conditions.You have a history of using drugs or drinking alcohol excessively.You have a mental illness.I have been diagnosed with breast cancer.You weigh less than 35 kilograms for every square meter of your height.My cancer has not spread to distant parts of my body.I am mostly self-sufficient and active.My breast cancer has spread to distant parts of my body or has come back in the same area.I have had radiation therapy on the same side of my chest before.You do not have significant drooping of the breasts.I am older than 18 years.My blood, heart, immune system, liver, and kidneys are functioning well.People with mental health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Breast Reconstruction with breast mesh
- Group 2: Breast Reconstruction without breast mesh
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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