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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.

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

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tianjin Medical University Cancer Institute and HospitalLead Sponsor

351 Previous Clinical Trials

171,937 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to enroll in the study at this time?

"Affirmative. In accordance with clinicaltrials.gov, this experiment is currently recruiting participants; it was initially advertised on August 1st 2021 and consequently updated last July 19th 2021. The research is looking for 300 volunteers at a single centre."

Answered by AI

What qualifications must a person meet to participate in this experiment?

"Patients that would like to partake in this research must have previously underwent radiation, and be between the ages of 18 – 70. The trial is accommodating around 300 participants."

Answered by AI

What is the present size of this research trial's cohort?

"Verified. According to clinicaltrials.gov, this ongoing medical research is still searching for participants. The trial was posted on August 1st 2021 and has undergone its last update on July 19th 2021; hence far, 300 people are required from one single site."

Answered by AI

To what extent is this experiment available for younger participants?

"Patients who meet the 18-year minimum and are no more than 70 years of age can register for this trial."

Answered by AI

What aims are being pursued with this investigation?

"This trial, evaluated over an average of 1 year, has the primary goal of assessing complication rates. Secondary outcomes include psychological evaluation by Breast-Q questionnaire - which gauges patient satisfaction with reconstruction - and aesthetic outcome measured via Harris evaluation score and another iteration of the Breast-Q questionaire; finally, total cost in RMB per capita is being tracked for this study as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Breast Mesh Used in Two-staged Breast Reconstruction

2021. "Breast Mesh Used in Two-staged Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04967976.

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