Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05003635
Status:
RECRUITING
Last Update Posted:
2022-08-03
First Post:
2021-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2021-07-22', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness measured in volume (MRI)', 'timeFrame': '1 year', 'description': '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).\n\nThe primary effectiveness endpoint is the Percentage Augmentation of the mastectomy defect at 12 months after AFT#1.'}], 'secondaryOutcomes': [{'measure': 'The quality of the reconstructed breast tissue as determined by MRI.', 'timeFrame': '12 months', 'description': 'Presence + description of necrotic cysts (Scale: amount of cyst and size in centimeters)'}, {'measure': 'The patient reported satisfaction at baseline and post-AFT using the Breast-Q Questionnaire', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Return of sensation to the breast as determined by Semmes-Weinstein monofilaments (map of the reconstructed breast mound with record of sensory levels)', 'timeFrame': '12 months'}, {'measure': 'Visual/standard photographic appearance of the reconstructed breast will be determined using a Likert scale 1-5.', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Difference in chest circumference between the peak of the reconstructed breast mound and the circumference just below the inframammary line', 'timeFrame': '12 months', 'description': 'Difference noted in centimeters (cm)'}, {'measure': 'Difference in bra cup size', 'timeFrame': '12 months', 'description': 'Cup size before and after reconstruction will be noted .'}, {'measure': '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.', 'timeFrame': '12 months', 'description': 'Volume change will be noted in cubic centimetre(cc)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fat grafting', 'lipoaspirate', 'fat injection', 'fat transfer', 'lipofilling', 'liposculpturing', 'lipoinjection', 'lipotransfer', 'breast reconstruction', 'external pre-expansion', 'BRAVA', 'EVE'], 'conditions': ['Breast Cancer Female']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '23 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 23-69\n* BMI 18-35 - stable weight, no fluctuations\n* 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\n* Agrees to have reconstruction at the time of study involving only autologous fat grafting (AFT)\n* Assessed by surgeon to have enough donor fat\n* 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.)\n\nExclusion Criteria:\n\n* untreated breast cancer\n* history of radiation therapy on the involved breast, even if it was part of a previous breast conservation procedure\n* completed chemotherapy course less than 2 months prior (acceptable to still be on aromatase inhibitors)\n* 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)\n* had mastectomy wound healing complications, e.g., seroma, wound breakdown, infection\n* mastectomy defect/scar has significant skin excess and deep folds adherent to the chest wall\n* has a pacemaker or aneurysm clips\n* pregnancy or breastfeeding\n* had a cardiac stent placed within the last 2 months\n* claustrophobic, as reported by patient\n* known current substance abuse, as reported by patient\n* history of silicone allergy, as reported by patient\n* history of Gadolinium allergy, as reported by patient\n* history of lidocaine allergy, as reported by patient\n* bleeding diathesis, whether primary or iatrogenic, as reported by patient cigarette smoker and/or Smokeless cigarette smokers, as reported by patient\n* 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'}, 'identificationModule': {'nctId': 'NCT05003635', 'acronym': 'EVE', 'briefTitle': 'External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery', 'orgStudyIdInfo': {'id': 'METC20-099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AFT+ EVEBRA device (intervention arm)', 'description': '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.\n\nPre-operatively patients are required to wear the device for a total of 200 hours.', 'interventionNames': ['Device: EVEBRA device']}, {'type': 'NO_INTERVENTION', 'label': 'AFT without EVEBRA device (control arm)', 'description': 'Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device.'}], 'interventions': [{'name': 'EVEBRA device', 'type': 'DEVICE', 'description': 'Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.', 'armGroupLabels': ['AFT+ EVEBRA device (intervention arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Andrzej Piatkowski, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Maastricht University Medical Center+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jan Maerten Smit, MD, MsC', 'role': 'CONTACT'}], 'facility': 'Amsterdam University Medical Center (VUMC)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Hengelo', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ute Schmidbauer, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Ziekenhuis groep Twente (ZGT)', 'geoPoint': {'lat': 52.26583, 'lon': 6.79306}}], 'centralContacts': [{'name': 'Maud Rijkx, MD, MsC', 'role': 'CONTACT', 'email': 'maud.rijkx@mumc.nl', 'phone': '+31 (0) 43 38 723 08'}], 'overallOfficials': [{'name': 'Andrzej Piatkowski de Gryzmala, MD, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}