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Recruiting NCT05003635

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

No phase Interventional Breast Cancer Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EVEBRA device.
Who it may be relevant to
Registry conditions: Breast Cancer Female. Basic parameters: 23 years — 69 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery

Overview

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.

Interventions

  • Device EVEBRA device
    Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.

Primary outcome measures

  • Effectiveness measured in volume (MRI) [Time frame: 1 year]
Secondary outcome measures (7)
  • The quality of the reconstructed breast tissue as determined by MRI. [Time frame: 12 months]
  • The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire [Time frame: 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) [Time frame: 12 months]
  • Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5. [Time frame: 12 months]
  • Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line [Time frame: 12 months]
  • Difference in bra cup size [Time frame: 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. [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Female
  • 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
  • known current substance abuse, as reported by patient
  • history of silicone allergy, as reported by patient
  • history of Gadolinium allergy, as reported by patient
  • history of lidocaine allergy, as reported by patient
  • bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarette smoker and/or Smokeless cigarette smokers, as reported by patient
  • medical conditions that preclude breast reconstruction including uncontrolled hypertension or diabetes, renal failure, steroid dependent asthma, and on immuno- suppressant medications, as reported by patient

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Netherlands · 3 centers
  • Maastricht University Medical Center+ — Maastricht
  • Amsterdam University Medical Center (VUMC) — Amsterdam
  • Ziekenhuis groep Twente (ZGT) — Hengelo

Identifiers

NCT: NCT05003635 · METC20-099

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗