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New treatment option for Breast Cancer Female
Official title External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
ClinicalTrials.gov ID: NCT05003635
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 23 to 69, women only
You may be able to join if
- 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...
- Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Maastricht, Limburg, Netherlands
- Amsterdam, Netherlands
- Hengelo, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 23 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maastricht, Limburg, Netherlands; Amsterdam, Netherlands; Hengelo, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.