NCT05003635 External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
| NCT ID | NCT05003635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-07-12 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2021-07-12 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Andrzej Piatkowski de Gryzmala, MD, MsC
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT05003635 clinical trial?
This trial is open to female participants only, aged 23 Years or older, up to 69 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05003635 currently recruiting?
Yes, NCT05003635 is actively recruiting participants. Contact the research team at maud.rijkx@mumc.nl for enrollment information.
Where is the NCT05003635 trial being conducted?
This trial is being conducted at Maastricht, Netherlands, Amsterdam, Netherlands, Hengelo, Netherlands.
Who is sponsoring the NCT05003635 clinical trial?
NCT05003635 is sponsored by Maastricht University Medical Center. The principal investigator is Andrzej Piatkowski de Gryzmala, MD, MsC at Maastricht University Medical Center. The trial plans to enroll 90 participants.
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