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RECRUITING NA

Breast Mesh Used in Two-staged Breast Reconstruction

NCT04967976 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • PROCEDURE TiLoop Bra mesh in expander-implant breast reconstrution
  • PROCEDURE sub-pectoral expander-implant breast reconstruction

Study Locations (6)

Texas

  • MD Anderson Cancer Center — Houston

Gansu

  • Gansu Provincial Cancer Hospital — Lanzhou

Jilin

  • Jilin Cancer Hospital — Ch’ang-ch’un

Tianjin Municipality

  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Zhejiang

  • Zhejiang Provincial People's Hospital — Hangzhou

Other

  • Technical University of Munich — Munich

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2021-08-01
Est. Completion 2026-08-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04967976

The ClinicalTrials.gov registry entry for NCT04967976 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tianjin Medical University Cancer Institute and Hospital, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which TiLoop Bra mesh in expander-implant breast reconstrution is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04967976 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Texas, Gansu, Jilin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04967976 about?

NCT04967976 is a clinical study titled "Breast Mesh Used in Two-staged Breast Reconstruction". 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, i...

What is the current status of trial NCT04967976?

This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2021-08-01. Estimated completion is 2026-08-01.

What conditions does trial NCT04967976 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Reconstruction, Radiation, Synthetic Mesh. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04967976?

The interventions under investigation include: TiLoop Bra mesh in expander-implant breast reconstrution (PROCEDURE), sub-pectoral expander-implant breast reconstruction (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04967976?

This trial is sponsored by Tianjin Medical University Cancer Institute and Hospital, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04967976 being conducted?

This trial has 6 study locations across Texas, Gansu, Jilin, Tianjin Municipality, Zhejiang. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial