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NCT05190978 · ClinicalTrials.gov registry record · NA
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
A NA study of Breast Cancer and Breast Implant; Complications, Infection or Inflammation, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05190978 is a NA study of Breast Cancer and Breast Implant; Complications, Infection or Inflammation that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 120 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05190978, a NA study of Breast Cancer and Breast Implant; Complications, Infection or Inflammation, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.
Conditions Studied
Interventions
- DEVICE Acellular Dermal Matrix
- PROCEDURE Reconstruction without ADM
Study Locations (1)
California
- University of California Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-10-20 |
| Est. Completion | 2026-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05190978
The ClinicalTrials.gov registry entry for NCT05190978 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Acellular Dermal Matrix is the first listed.
NCT05190978 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05190978 about?
NCT05190978 is a clinical study titled "Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction". Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indic...
What is the current status of trial NCT05190978?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2022-10-20. Estimated completion is 2026-04-30.
What conditions does trial NCT05190978 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Implant; Complications, Infection or Inflammation.
What interventions are being tested in trial NCT05190978?
The interventions under investigation include: Acellular Dermal Matrix (DEVICE), Reconstruction without ADM (PROCEDURE).
Who is sponsoring clinical trial NCT05190978?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05190978 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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