NCT05190978 Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
| NCT ID | NCT05190978 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-10-20 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-10-20 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders * Prophylactic and oncologic mastectomies are both acceptable * Nipple sparing and skin sparing mastectomy techniques are both acceptable Exclusion Criteria: * Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast * Bilateral reconstruction patients undergoing contralateral submuscular reconstruction * Direct-to-implant reconstruction * Pregnancy * Delayed reconstruction
Contact & Investigator
Michael Delong, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05190978 clinical trial?
This trial is open to female participants only, aged 22 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05190978 currently recruiting?
Yes, NCT05190978 is actively recruiting participants. Contact the research team at mdelong@mednet.ucla.edu for enrollment information.
Where is the NCT05190978 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05190978 clinical trial?
NCT05190978 is sponsored by University of California, Los Angeles. The principal investigator is Michael Delong, MD at University of California, Los Angeles. The trial plans to enroll 120 participants.
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