Evaluating a new breast reconstruction technique using a vacuum device
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
This study is testing a new breast reconstruction method using a vacuum device to see if it helps women with breast cancer feel better and have better results after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 23 Years to 69 Years |
| Sex | Female |
| Sponsor | Maastricht University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Maastricht, Limburg and 2 other locations) |
| Trial ID | NCT05003635 on ClinicalTrials.gov |
What this trial studies
This multicentre randomized controlled trial evaluates a novel breast reconstruction technique known as autologous fat transfer (AFT) in female patients with breast cancer. Participants scheduled for mastectomy will be randomly assigned to receive AFT with the EVEBRA device or without it. The study aims to assess various outcomes including volume, quality of life, aesthetic results, complications, and oncological safety associated with the use of the device. The trial seeks to provide insights into the effectiveness of this innovative approach to breast reconstruction.
Who should consider this trial
Good fit: Ideal candidates are females aged 23-69 who have undergone a total mastectomy and are suitable for autologous fat grafting.
Not a fit: Patients with untreated breast cancer or those who have received radiation therapy on the involved breast may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the outcomes of breast reconstruction for patients with breast cancer, improving both aesthetic results and quality of life.
How similar studies have performed: Other studies have explored autologous fat transfer in breast reconstruction, but the specific use of the EVEBRA device represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Maastricht, Limburg and 2 other locations
- Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (Recruiting)
- Amsterdam University Medical Center (VUMC) — Amsterdam, Netherlands (Recruiting)
- Ziekenhuis groep Twente (ZGT) — Hengelo, Netherlands (Recruiting)
Study contacts
- Principal investigator: Andrzej Piatkowski de Gryzmala, MD, MsC — Maastricht University Medical Center
- Study coordinator: Maud Rijkx, MD, MsC
- Email: maud.rijkx@mumc.nl
- Phone: +31 (0) 43 38 723 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.