RECRUITING

Breast Mesh Used in Two-staged Breast Reconstruction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

Official Title

A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.

Quick Facts

Study Start:2021-08-01
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04967976

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosed with breast cancer
  2. 2. More than 18 years old
  3. 3. Karnofsky Performance Status (KPS) larger than 80
  4. 4. No clinical or imaging evidence of distant metastasis
  5. 5. BMI \< 35kg/m2
  6. 6. Patients with no or mild breast ptosis
  7. 7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
  8. 8. Mental Health Patient
  1. 1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion

Contacts and Locations

Study Contact

Jian Yin
CONTACT
+86-22-23340123
yinjian@tjmuch.com
Bowen Ding
CONTACT
+86-22-23340123
ding_x87@126.com

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2021-08-01
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • breast reconstruction
  • radiation
  • synthetic mesh

Additional Relevant MeSH Terms

  • Breast Cancer
  • Radiation
  • Breast Reconstruction
  • Synthetic Mesh