Breast Cancer FemaleEVENCT05003635
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
A study testing EVEBRA device in people with Breast Cancer Female, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 69 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- EVEBRA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesNetherlands
- Study dates
- 12 Jul 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam University Medical Center (VUMC)
Amsterdam
Jan Maerten Smit, MD, MsC
- Recruiting
Ziekenhuis groep Twente (ZGT)
Hengelo
Ute Schmidbauer, MD, PhD
- Recruiting
Maastricht University Medical Center+
Maastricht, Limburg, 6229 HX
Andrzej Piatkowski, MD, PhD
About this study
Official title: External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
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.
- Conditions
- Breast Cancer Female
- Being tested
- EVEBRA device
- Keywords
- fat grafting, lipoaspirate, fat injection, fat transfer, lipofilling, liposculpturing, lipoinjection, lipotransfer, breast reconstruction, external pre-expansion, BRAVA, EVE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVEBRA deviceDevice
Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.
| Study group | Role | What they receive |
|---|---|---|
| AFT+ EVEBRA device (intervention arm) | Active comparator | Before and after the AFT surgery, patients are required to wear the EVEBRA expansion device for a total duration of 4 weeks. Thereafter patients will receive a PexyBra over the reconstructed breast.
Pre-operatively patients are required to wear the device for a total of 200 hours. Receives: Device: EVEBRA device |
| AFT without EVEBRA device (control arm) | No intervention | Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness measured in volume (MRI)
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.
Measured: 1 year
Secondary outcomes (7)
The quality of the reconstructed breast tissue as determined by MRI.
Presence + description of necrotic cysts (Scale: amount of cyst and size in centimeters)
Measured: 12 months
The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire
Qscore will be used to assess final scores. As described in the BREAST-Q Module, summed scores will be converted into a score from 0 (worst) to 100 (best) per domain. Higher scores reflect a better outcome.
Measured: 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)
Measured: 12 months
Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5.
The aesthetic improvement will be rated using pre-operative and one year post-operative 2D images by a group of experts, breast cancer patients and age-matched male and female laymen. All parties rate the pre-/post- 3D images on a Likert scale (5 points) with one indicating no improvement and 5 indicating perfect improvement.
Measured: 12 months
Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line
Difference noted in centimeters (cm)
Measured: 12 months
Difference in bra cup size
Cup size before and after reconstruction will be noted .
Measured: 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.
Volume change will be noted in cubic centimetre(cc)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start12 Jul 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Andrzej Piatkowski de Gryzmala, MD, MsC, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003635
- Sponsor's protocol ID
- METC20-099
- Acronym
- EVE
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT05003635
- Acronym / sponsor ID
- EVE / METC20-099
- Conditions
- Breast Cancer Female
- Keywords
- fat grafting, lipoaspirate, fat injection, fat transfer, lipofilling, liposculpturing, lipoinjection, lipotransfer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFT+ EVEBRA device (intervention arm) | Active comparator | Device: EVEBRA deviceBefore and after the AFT surgery, patients are required to wear the EVEBRA expansion device for a total duration of 4 weeks. Thereafter patients will receive a PexyBra over the reconstructed breast. Pre-operatively patients are required to wear the device for a total of 200 hours. |
| AFT without EVEBRA device (control arm) | No intervention | –Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device. |
Who may qualify
- Ages
- 23 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVEBRA deviceWear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day. | Device | AFT+ EVEBRA device (intervention arm) |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrzej Piatkowski de Gryzmala, MD, MsC principal investigator
Maastricht University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVEBRA device in people with Breast Cancer Female, run by Maastricht University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maud Rijkx, MD, MsC (+31 (0) 43 38 723 08, maud.rijkx@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness measured in volume (MRI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022; AzTrials last refreshed its copy on 26 Oct 2026.