Clinical Trial

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

Study acronym: EVE

Recruiting

Summary

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2021-08-05.

Trial Details

NCT Number	NCT05003635
Lead Sponsor	Maastricht University Medical Center Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions	Breast Cancer Female
Enrollment	90 participants
Start Date	2021-07-12
Primary Completion	2026-10 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2022-08-03