Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:49 AM
Study NCT ID:
NCT07340632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
B4P Trial - BLOOM43 for Preconditioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009336', 'term': 'Necrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of the device', 'timeFrame': '90 days', 'description': 'Monitoring AEs, ARs, SAEs, SARs, UARs and USARs'}, {'measure': 'Participant experience', 'timeFrame': '30 days', 'description': "Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants."}], 'secondaryOutcomes': [{'measure': 'Mastectomy skin flap necrosis', 'timeFrame': '90 days', 'description': 'Proportion of participants experiencing mastectomy skin flap necrosis and the rates of hospital re-admission and surgical re-intervention due to this'}, {'measure': 'Compliance', 'timeFrame': '1 day', 'description': 'Proportion of participants who are compliant with the preconditioning protocol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mastectomy skin flap necrosis', 'Breast reconstruction', 'Breast surgery', 'Preconditioning', 'Skin necrosis'], 'conditions': ['Skin Necrosis', 'Breast Reconstruction', 'Breast Surgery']}, 'referencesModule': {'references': [{'pmid': '24908545', 'type': 'BACKGROUND', 'citation': 'Jeevan R, Cromwell DA, Browne JP, Caddy CM, Pereira J, Sheppard C, Greenaway K, van der Meulen JH. Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England. J Plast Reconstr Aesthet Surg. 2014 Oct;67(10):1333-44. doi: 10.1016/j.bjps.2014.04.022. Epub 2014 May 14.'}, {'pmid': '28331365', 'type': 'BACKGROUND', 'citation': 'Robertson SA, Jeevaratnam JA, Agrawal A, Cutress RI. Mastectomy skin flap necrosis: challenges and solutions. Breast Cancer (Dove Med Press). 2017 Mar 13;9:141-152. doi: 10.2147/BCTT.S81712. eCollection 2017.'}, {'pmid': '24011908', 'type': 'BACKGROUND', 'citation': 'Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4.'}, {'pmid': '32505626', 'type': 'BACKGROUND', 'citation': 'Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21.'}, {'pmid': '30656059', 'type': 'BACKGROUND', 'citation': 'Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. This study aims to understand a participant's experience of the device, including its usability and acceptability.\n\nParticipants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All females over the age of 18 years (no maximum age limit)\n* Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and/or implant)\n\nExclusion Criteria:\n\n* Delayed (two-stage) breast reconstruction patients\n* Patients undergoing simple mastectomy or wide local excision of a breast tumour\n* Inflammatory breast cancer patients\n* Patients with ulcerated breast tumours\n* Patents with T4 breast cancer\n* Presence of open breast skin wounds, or infected or inflamed breast skin\n* Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device'}, 'identificationModule': {'nctId': 'NCT07340632', 'briefTitle': 'B4P Trial - BLOOM43 for Preconditioning', 'organization': {'class': 'INDUSTRY', 'fullName': 'Plexaa Ltd'}, 'officialTitle': 'BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study', 'orgStudyIdInfo': {'id': 'B4PTrial'}, 'secondaryIdInfos': [{'id': 'NIHR206435', 'type': 'OTHER', 'domain': 'National Institute for Health and Care Research (NIHR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All participants (single arm)', 'description': "Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their ipsilateral breast (the breast to be operated on) and the preconditioning protocol will be undertaken 12 hours before surgery - i.e. the evening before. Patients will then attend hospital for their breast surgery the next day as planned. For the patients undergoing bilateral skin/nipple-sparing mastectomy with immediate reconstruction, they will be asked to precondition only the right breast.", 'interventionNames': ['Device: BLOOM43']}], 'interventions': [{'name': 'BLOOM43', 'type': 'DEVICE', 'description': 'BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.', 'armGroupLabels': ['All participants (single arm)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Saahil Mehta', 'role': 'CONTACT', 'email': 'saahil@plexaa.com', 'phone': '447711183551'}, {'name': 'Hadyn Kankam', 'role': 'CONTACT', 'email': 'hadyn@plexaa.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Plexaa Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Portsmouth Hospitals NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}