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Clinical Trials/NCT05003635
NCT05003635
Recruiting
Not Applicable

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery

Maastricht University Medical Center3 sites in 1 country90 target enrollmentStarted: July 12, 2021Last updated:
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ConditionsBreast Cancer Female

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
90
Locations
3
Primary Endpoint
Effectiveness measured in volume (MRI)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
23 Years to 69 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 23-69
  • •BMI 18-35 - stable weight, no fluctuations
  • •Have undergone a total mastectomy at least 3 months prior the study, whether therapeutic or prophylactic, whether unilateral or bilateral, with no resection of the pectoralis muscle
  • •Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)
  • •Assessed by surgeon to have enough donor fat
  • •Passes a 20-minutes tolerance test with EVEBRA Device. (Patient will be fitted, instructed on the use, and given the EVEBRA Device to try in the office for 20 minutes. She passes if she tolerates its use, feels comfortable wearing it, and is able to comply with the required wear of the device.)

Exclusion Criteria

  • •untreated breast cancer
  • •history of radiation therapy on the involved breast, even if it was part of a previous breast conservation procedure
  • •completed chemotherapy course less than 2 months prior (acceptable to still be on aromatase inhibitors)
  • •except for the biopsy leading to the diagnosis of cancer, had surgery to breast prior to the mastectomy (e.g., multiple biopsies, implant augmentation, mastopexy, fat grating)
  • •had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection
  • •mastectomy defect/scar has significant skin excess and deep folds adherent to the chest wall
  • •has a pacemaker or aneurysm clips
  • •pregnancy or breastfeeding
  • •had a cardiac stent placed within the last 2 months
  • •claustrophobic, as reported by patient

Outcomes

Primary Outcomes

Effectiveness measured in volume (MRI)

Time Frame: 1 year

All women will have an MRI for Baseline Breast Volume measurement at the time of enrollment. Final breast volume will be also determined by MRI 6 months after the first grafting procedure (AFT#1). The primary effectiveness endpoint is the Percentage Augmentation of the mastectomy defect at 12 months after AFT#1.

Secondary Outcomes

  • The quality of the reconstructed breast tissue as determined by MRI.(12 months)
  • Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5.(12 months)
  • The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire(12 months)
  • Return of sensation to the breast as determined by Semmes-Weinstein monofilaments (map of the reconstructed breast mound with record of sensory levels)(12 months)
  • Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line(12 months)
  • Difference in bra cup size(12 months)
  • Difference in Breast Volume from the randomization baseline after the three sessions of fat grafting (Final Reconstructed Breast Volumes) as measured by the validated Vectra 3D imaging system and the MRI.(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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