[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Luminate Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100603883","the-lilac-device-trial---impact-a-clinical-investigation-on-improving-peripheral-neuropathy-induced-by-chemotherapy-with-advanced-compression-technology---a-safety-and-efficacy-study-100603883",false,"NCT07142304","The Lilac Device Trial - IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study","IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Chemotherapy With Advanced Compression Technology - A Safety and Efficacy Study","IMPACT","Inclusion Criteria:\n\nTo be eligible to participate in this clinical investigation, participants must meet ALL the following criteria:\n\n1. Adults ≥ age 18 with diagnosed solid tumor cancer, who have been deemed appropriate for neo-adjuvant or adjuvant chemotherapy.\n2. Planned intravenous treatment with at least 4 cycles of chemotherapy, with no planned treatment pause for surgery,\n\n   * With one of the following treatments:\n\n     * Chemotherapy regimens based on Oxaliplatin\n\n       * FOLFOX every 2 weeks\n       * FOLFIRINOX every 2 weeks\n     * Chemotherapy regimens based on single-agent Paclitaxel\n\n       * Paclitaxel weekly\n       * Paclitaxel every 3 weeks\n     * Chemotherapy regimens based on Paclitaxel + Carboplatin\n\n       * Paclitaxel weekly with Carboplatin weekly\u002Fevery 3 weeks\n       * Paclitaxel every 3 weeks with Carboplatin every 3 weeks\n   * Concurrent administration of the chemotherapies listed in the inclusion criteria with or without targeted agents\u002Fimmunotherapy at standard doses is allowed (such as trastuzumab, pertuzumab, bevacizumab, pembrolizumab or other immune checkpoint inhibitors).\n3. Hands and feet size within the specified study sizing range.\n4. Plan to complete taxane- or platinum-based chemotherapy in ≤ 12 months.\n5. ECOG performance status 0 - 2.\n6. Willing and able to sign informed consent.\n7. Willing to comply with and tolerate all study procedures including:\n\n   * Wearing the Lilac Glove and Boot devices for the prescribed duration (devices to be fitted before infusion, and worn during infusion and for up to one (1) hours post infusion),\n   * Complete all study related questionnaires.\n8. Participants must be able to complete participant specific questionnaires in the languages available to the study\n\nExclusion Criteria:\n\nParticipants are not eligible to participate in the clinical trial if they meet ANY of the following criteria:\n\n1. Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade \\> 0.\n2. Prior exposure to neurotoxic chemotherapy in the previous 1 year, counted as the period since the last neurotoxic chemotherapy treatment (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).\n3. Positive pregnancy test at baseline for participants with child bearing potential, as per standard of care.\n4. Known or suspected allergy or hypersensitivity to any component of the Lilac Glove or Boot device that comes into contact with the study participant. Caution: This product contains natural rubber latex, which may cause allergic reactions.\n5. Any open wounds, sores, cysts or injury on the participant's hand or on part of the upper arm where the device will be applied or on the participant's feet or part of the lower leg where the device will be applied, which in the opinion of the investigator will not be healed prior to infusion commencing or who in the opinion of the investigator will be inappropriate for inclusion in this study.\n6. Clinically significant peripheral arterial ischemia, as per standard of care, in the opinion of the investigator.\n7. Untreated or uncontrolled hypertension, as per standard of care.\n8. Poorly controlled diabetes, as per standard of care, in the opinion of the investigator.\n9. Weight greater than 140 kg at the time of enrollment.\n10. An existing history or suspicion of presence of hand or foot metastasis.\n11. Use of other investigational devices or active compression\u002F cryotherapy interventions for CIPN prevention or management during the study.\n12. Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine.\n13. Participants who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with the requirements of the study.\n14. Participants with cognitive impairment, psychiatric conditions, or mobility limitations that would prevent compliance with study procedures (e.g., inability to wear the device, complete questionnaires, or attend follow-up visits).\n15. Current participation in a clinical study or within the last 30 days prior to screening that may cause peripheral neuropathy.\n16. Participation in this study at an earlier stage.","ALL","18 Years",{"count":20,"type":21},142,"ESTIMATED","INTERVENTIONAL",[24],"NA","Chemotherapy drugs, used in the treatment of cancer, have the potential of inducing peripheral neuropathy (PN) as a side effect. This side effect is commonly referred to as CIPN, or chemotherapy-induced peripheral neuropathy.\n\nThe Lilac Glove and Boot devices apply a low pressure across the surface of the hands and feet, respectively, to reduce access of chemotherapy to the peripheral nerves on the hands and feet. The small amount of pressure reduces the level of chemotherapy reaching the peripheral nerves, hence increasing the likelihood of nerve preservation during treatment and thus may potentially temporarily prevent the onset of moderate to severe PN symptoms induced by chemotherapy in the hands and feet while receiving treatment",[27],"Chemotherapy Induced Peripheral Neuropathy (CIPN)","RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2025-10-03",{"date":36,"type":21},"2026-10",{"name":38,"class":39},"Luminate Medical, Inc.","INDUSTRY",18,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100576498","the-lily-device-trial-100576498","NCT06786078","The Lily Device Trial","PREVAIL: a Clinical Investigation on Providing Reduced Effects of Visible Alopecia Caused by Chemotherapy Using the Lily Device - a Safety and Efficacy Study.","PREVAIL","Inclusion Criteria:\n\n1. Adults ≥ age 18 with breast cancer stage 1, 2 or 3, who have been deemed appropriate for (neo-)adjuvant chemotherapy and have not yet begun any systemic therapy.\n2. Planned intravenous chemotherapy in the adjuvant or neoadjuvant setting with at least 4 cycles of chemotherapy, with one of the following regimens:\n\n   * Doxorubicin 60 mg\u002Fm\\^2 with cyclophosphamide 600 mg\u002Fm\\^2 every 2-3 weeks\n   * Doxorubicin 60 mg\u002Fm\\^2 with fluorouracil 500 mg\u002Fm\\^2 and cyclophosphamide 500 mg\u002Fm\\^2 every 2-3 weeks\n   * Paclitaxel 80-90 mg\u002Fm\\^2 weekly (every 3 weeks constitutes a cycle)\n   * Paclitaxel 175 mg\u002Fm\\^2 every 2-3 weeks\n   * Paclitaxel 80-90 mg\u002Fm\\^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 1.5 every week\n   * Paclitaxel 80-90 mg\u002Fm\\^2 weekly (every 3 weeks constitutes a cycle) with carboplatin AUC 5-6 every 3 weeks\n   * Docetaxel 75-100 mg\u002Fm\\^2 every 3 weeks\n   * Docetaxel 75 mg\u002Fm\\^2 with cyclophosphamide 600 mg\u002Fm\\^2 every 3 weeks\n   * Docetaxel 75 mg\u002Fm\\^2 with carboplatin AUC 5-6 every 3 weeks\n\n     * Concurrent administration with targeted agents\u002Fimmunotherapy at standard doses (such as trastuzumab, pertuzumab, pembrolizumab) is allowed. Duration of targeted agents\u002Fimmunotherapy is at the investigator's discretion.\n     * Participants on AC-T regimens who are prescribed with at least 4 treatments with anthracycline followed by at least 4 treatments with taxane are eligible for the study. In terms of data analysis, these participants are counted towards the anthracycline group\n3. Head size within the specified study sizing range.\n4. Plan to complete chemotherapy in ≤ 12 months.\n5. Willing and able to sign informed consent.\n6. Willing to comply and tolerate all study procedures including:\n\n   * Wearing the Lily device for the prescribed duration (device to be fitted before chemotherapy infusion, and worn during infusion and for at least two (2) hours and up to four (4) hours post infusion),\n   * Complete all study related questionnaires.\n   * Having photographs taken of the head at each visit.\n\nTo note:\n\n* Participants who experience a hypersensitivity reaction to chemotherapy are allowed to continue in the study if the standard doses are maintained.\n* Participants on the chemotherapy plan KEYNOTE-522 are eligible for this study.\n* If a participant is prescribed a different chemotherapy treatment plan, they may be eligible for the study only if prior Sponsor approval is obtained.\n\nExclusion Criteria:\n\n1. Baseline alopecia defined as CTCAE v5.0 grade \\> 0.\n2. History of autoimmune disease associated with hair loss, e.g., alopecia areata, systemic lupus.\n3. History of whole brain irradiation.\n4. Recent chemotherapy (≤ 2 years), which caused hair loss.\n5. Participants who are receiving or are planning to receive hormone replacement therapy or anti-estrogen therapy during the study, whereby the therapy in question has a known profile for causing hair loss.\n6. Prescribed chemotherapy regimen with concurrent administration of taxane-based and anthracycline-based chemotherapy (i.e., infusion of both taxane and anthracycline agents on the same day).\n7. Positive pregnancy test at baseline for participants with childbearing potential, as per standard of care for chemotherapy patient.\n8. Known or suspected allergy or hypersensitivity to any component of the Lily device that comes into contact with the study participant.\n9. Participants with a history of Temporomandibular Joint Disorder.\n10. Any open wounds or sores on the participant's scalp or on part of the face where the device will be applied, which in the opinion of the investigator will not be healed prior to chemotherapy commencing.\n11. Serious infection or medical illness which would jeopardize the ability of the participant to complete the planned chemotherapy.\n12. Intercurrent life-threatening malignancy.\n13. An existing history of scalp metastases or suspicion of presence of scalp metastasis.\n14. Use of a cold cap, scalp cooling device or any other hair loss reduction device during the study.\n15. Participants who, in the opinion of the investigator, will be inappropriate for inclusion into this study or will not comply with requirements of the study.\n16. Participants who do not have the mental or physical ability to comply with time schedules and further study procedures.\n17. Current participation in a clinical study or within the last 30 days prior to screening that may cause hair loss.\n18. Participation in this study at an earlier stage.",{"count":50,"type":21},85,[24],"The goal of this clinical trial is to test if the Lily Device works to reduce chemotherapy induced hair loss in patients. It will also learn about the safety of the Lily Device. The main questions it aims to answer is:\n\n* Do patient preserve their hair using the Lily Device after 4 cycles of chemotherapy, when hair preservation is a Grade ≤1 graded by an independent healthcare professional on the Common Terminology Criteria for Adverse Events (CTCAE)?\n* What is the subject incidence of Grade 1 or above Adverse Device Events (ADE's)?",[54],"Chemotherapy Induced Alopecia","2025-01-14",{"date":57,"type":32},"2025-01-22",{"date":59,"type":32},"2024-12-20",{"date":61,"type":21},"2025-11",{"name":38,"class":39},5,""]