[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Royal Wolverhampton Hospitals NHS Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":239},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,39,60,82,103,125,143,170,199,216],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100633883","real-world-maia-uk-outcomes-100633883",false,"NCT07532473","REal World MAIA UK OutcomEs","A Retrospective Study of Clinical Outcomes in Newly Diagnosed, Transplant Ineligible Multiple Myeloma Patients Treated With Daratumumab, Lenalidomide and Dexamethasone (DRd) Outside of Clinical Trials in the UK","REMAKE","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of NDMM\n* Not eligible for autologous stem cell transplant at diagnosis\n* Received frontline DRd treatment following NICE approval (post-September 2023)\n* Minimum 3 months of follow-up data available\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial for first-line therapy\n* Insufficient treatment or follow-up data for analysis\n* DRd used in relapsed\u002Frefractory setting rather than newly diagnosed disease","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","This study will describe the use of triplet therapy with daratumumab, lenalidomide and dexamethasone (DRd) in the treatment of for transplant ineligible (TIE) untreated myeloma outside of clinical trials and assess the associated clinical outcomes.",[25],"Myeloma","NOT_YET_RECRUITING","2026-04-15",{"date":29,"type":30},"2026-04-20","ACTUAL",{"date":32,"type":21},"2026-07",{"date":34,"type":21},"2028-07",{"name":36,"class":37},"The Royal Wolverhampton Hospitals NHS Trust","OTHER_GOV",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":38},"100628617","variation-in-referral-thresholds-in-the-chronic-lymphocytic-leukaemia-pathway-100628617","NCT07463976","variaTIon in Referral Thresholds in the Chronic Lymphocytic LeukaEmia Pathway","variaTIon in Referral Thresholds in the Chronic Lymphocytic LeukaEmia Pathway (TITLE CLL)","TITLE CLL","Inclusion Criteria:\n\n* Primary Care Provider\n* Clinical Nurse Specialist\n\nExclusion Criteria:\n\n\\-",{"count":48,"type":21},130,"This study will use surveys within primary and secondary care to explore referral patterns and healthcare professional (HCP) decision-making and advice for haematological malignancies, identify inequalities, and establish best practice for CLL referrals and specialist support. The project will allow us to understand and 'map' variations in practice across the West Midlands region with regard to referrals for CLL from primary care physicians to haematology services in secondary care.\n\nSpecific objectives are to:\n\n1. Identify service variations by using surveys to assess differences in CLL service provision across primary and secondary care in the West Midlands\n2. Investigate service variations by describing the key characteristics of responding primary care practices (practice size, number of GPs, Integrated Care Board (ICB) locality, deprivation quartile)\n3. Propose strategies to improve equity that will enhanced patient outcomes and reduce inequalities in care for CLL patients, aiming to ensure consistent standards for referral and management across different care settings.",[51,52],"Chronic Lymphocytic Leukemia","Haematological Malignancy","2026-04-08",{"date":55,"type":30},"2026-04-13",{"date":32,"type":21},{"date":58,"type":21},"2027-07",{"name":36,"class":37},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":38},"100606430","ibdminds---mapping-the-influence-of-anxiety-and-depression-on-ibd-100606430","NCT07175454","IBDminds - Mapping the Influence of aNxiety and DepreSsion on IBD","A Study to Describe the Burden of Mental Ill Health in Inflammatory Bowel Disease Patients Using Advanced Therapies, and to Identify Any Associations Between Common Mental Health Problems and the Efficacy of Such Advanced Therapies (IBDmind)","IBDminds","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of ulcerative colitis, or Crohn's disease, based upon either the outcome of the local multidisciplinary team, clinic documentation or in the opinion of the investigator\n* Patients receiving maintenance infliximab or vedolizumab by regular intravenous infusion\n* Patients willing and able to give informed consent\n* Patients aged 16 or over\n\nExclusion Criteria:\n\n* Patients cannot be recruited while receiving their loading dose of infusions, but may be included once complete.\n* Patients should not currently be planned for surgery within the next 12 months\n* Patients should not currently be planned to switch to another advanced therapy within the next 12 months\n* Patients should not currently be planned for a drug holiday within the next 12 months\n* Patients should not have a stoma (This would invalidate the PRO-2 outcome measure)\n* Patients should not currently be pregnant\n* Patient currently receiving subcutaneous infliximab or vedolizumab","16 Years",{"count":70,"type":21},450,"People with Inflammatory bowel disease (IBD) can get challenging symptoms. Things like diarrhoea, tummy pain and being tired all the time are common. People often get IBD in their teens or twenties. They often find working, studying and relationships hard. IBD can't be cured, so it lasts for life.\n\nWhen IBD is hard to treat, we use advanced treatments, but these don't always work. When they do work the effect can wear off. This happens in 2 of 5 people within a year in research studies. There are some things that we know make them wear off. There are lots more reasons that we don't understand yet. We think anxiety, depression and stress make these treatments more likely to wear off. Previous research has suggested that people with IBD do worse if they have anxiety, depression or stress.\n\nThe investigators want people with IBD to complete questionnaires to see if they are affected by anxiety, depression or stress when they are taking advanced therapies. The investigators will follow those people to see if the effect of their treatment wears off.\n\nPeople living with IBD will contribute to the running and fine tuning of this research. Many of those that have engaged with us so far have said that their disease was worse when their mental health was worse. They were generally supportive of this study to see how anxiety, depression and stress effects IBD in people using advanced therapies.\n\nThe investigators have talked to a national charity about our work. They will help share the findings so that patients, care givers and other stakeholders will be able to read about them. The results will be published so that doctors and researchers can use them.",[73,74],"Inflammatory Bowel Diseases","Mental Health Issue",{"date":76,"type":30},"2026-04-09",{"date":78,"type":21},"2026-05",{"date":80,"type":21},"2028-05",{"name":36,"class":37},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":22,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":38},"100532843","vitiligo-registry-for-adults-and-children-in-the-uk-100532843","NCT06218082","Vitiligo Registry for Adults and Children in the UK","Vitiligo Registry for Adults and Children in the UK (VIRTUAL-UK)","VIRTUAL-UK","Inclusion Criteria:\n\n1. Paediatric and adult patients with vitiligo under management in secondary care.\n2. Written informed consent for study participation obtained from the patient or parents \u002F legal guardian, with assent as appropriate by the patient, depending on the level of understanding.\n3. Participants consent to participate in long-term follow up and access to all relevant medical records as needed by the study team\n4. Clinical diagnosis of vitiligo made by a dermatologist\n5. Willingness to comply with all study requirements.\n6. Competent use of English language, according to patient's age (capable of understanding patient questionnaires).\n\nExclusion Criteria:\n\n1. Insufficient understanding of the study by the patient and\u002For parent\u002Fguardian.\n2. Patients with vitiligo\u002Ftheir parents or guardians, who do not provide consent for participation.",{"count":91,"type":21},30,"1 Year","Vitiligo is the most common depigmentation disorder affecting around 1% of the population worldwide. Fifty two percent of patients develop vitiligo before the age of 20 and around 80% develop vitiligo before the age of 30 years old.1 Vitiligo often presents in childhood and tends to be a lifelong disease, requiring prolonged courses of phototherapy.\n\nCurrently no national or international registry for patients with vitiligo exists. Individual dermatologists maintain a database of such patients, however no coordinated efforts have been made to combine these individual registries into a broader national registry. Finally, recently published British Association of Dermatologists (BAD) guideline for the management of vitiligo, recommended the development of a national registry for people with vitiligo undergoing systemic or light therapy to identify outcomes and safety.",[95,96],"Dermatologic Disease","Vitiligo",{"date":76,"type":30},{"date":99,"type":21},"2026-05-15",{"date":101,"type":21},"2030-02",{"name":36,"class":37},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100467943","feasibility-study-to-evaluate-the-role-of-a-novel-device-in-childbirth-100467943","NCT05373342","Feasibility Study to Evaluate the Role of a Novel Device in Childbirth","Feasibility Study to Evaluate the Role of a Novel Device in the Prevention of Retained Items In Childbirth Environment- Clinical Usability Pilot Study","PRINCE","Inclusion Criteria:\n\n* Midwifery lead and consultant lead patient older than 18 years.\n* Consented to participation after an informed choice.\n\nExclusion Criteria:\n\n• Under 18 years of age\n\nAntenatal (before labour):\n\n* Patients who have a high risk of expected\u002Funexpected maternal, fetal or neonatal deterioration such that during birth, the focus of attention would be towards safe patient care and observation required for using the swab-counter device system would not be possible such as :\n* Patients who are seriously unwell and require high dependency care.\n* Maternal cardiac conditions\n* Severe pre-eclampsia\n* Fetal anomalies where neonatal deterioration is expected (These will be relatively rare conditions where the doctor\u002Fmidwife would decide to not recruit the patient)\n\nIntrapartum and postpartum factors:\n\n* Patient having an emergency Caesarean section instead of a vaginal birth due to maternal or fetal indication.\n* Eclampsia (seizure\u002Ffitting in labour or after delivery)\n* Maternal cardiac conditions requiring high dependency care\n* Severe sepsis requiring high dependency care\n* Fetal anomalies where neonatal deterioration is expected",true,"FEMALE",{"count":114,"type":21},70,"Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest \"Never Events\" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Retained surgical items have 70% re-interventions, reaching 80% morbidity and 35% mortality.\n\nSwabs or sponges are like small towels that soak up blood and body fluids so that the surgeon can visualise the operating area effectively. Swabs are used in all areas of surgery which include operations on the tummy, chest, limbs. They are also used in the vagina during childbirth, to assess for tears and to minimise blood oozing from the vagina.\n\nThe common risk factors for this error are out of hours surgical or childbirth procedures, multiple handovers in the care of the patient, raised BMI (Body Mass Index) and unplanned change to the operative intervention.\n\nAs the name suggests, a 'never event' should never happen in the first place. Never. Unfortunately, this is not the case. Incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice.\n\nnever-event incidents involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?",[117,118],"Surgical Item, Retained","Childbirth",{"date":76,"type":30},{"date":121,"type":21},"2026-09",{"date":123,"type":21},"2027-09",{"name":36,"class":37},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":38},"100380471","zn-ddc-to-target-hypoxia-nfkappab-cscs-pathway-in-multiple-myeloma-100380471","NCT04234022","Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway in Multiple Myeloma","Zn-DDC to Target Hypoxia-NFkappaB-CSCs Pathway and Improve the Treatment Outcomes of Haematological Malignancies - A Translation Bench Study","Inclusion Criteria:\n\n* Patients diagnosed with haematological malignancy - either myeloma or acute leukaemia\n* Patients must be 18 years or over\n* Patients must be willing and able to give informed consent\n\nExclusion Criteria:\n\n* Pregnant patients will not be entered",{"count":114,"type":21},"The outlook for patients with haematological malignancies remains challenging. It has been shown in some early cancer studies that a particular drug called Zn-DDC otherwise known as Imuthiol is highly toxic to cancer stem cells. Imuthiol has been intravenously used in clinical trials with an excellent safety record. Recent novel therapy and immunotherapy in haematological malignancies have improved outcome and survival but come with an increasing cost burden. Imuthiol could be an ideal affordable drug to study on it's own as well as in combination with other drugs in myeloma and other haematological malignancies. This may lead to potential combination therapies which will be very effective as well as affordable in the future. There is the need to look to see if this drug, Imuthiol and along with complementary drugs lenalidomide (Revlimid) and pomalidomide (Pomalyst) can help in haematological malignancy treatment. In order to do this there is the need to see how the cancer cells respond to the drugs in the laboratory before being able to trial the drug (or combination of drugs) out for treatment. The success of this study may lead to quick translation of Imuthiol into haematological malignancy treatment.",[135],"Multiple Myeloma","RECRUITING",{"date":76,"type":30},{"date":139,"type":30},"2021-10-22",{"date":141,"type":21},"2027-12",{"name":36,"class":37},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":4},"100600163","artificial-intelligence-for-reconstruction-of-echocardiography-studies-100600163","NCT07093918","Artificial Intelligence for Reconstruction of Echocardiography Studies","Echocardiographic Detection of Cardiotoxicity Using the Ventripoint (VMS) 3D AI Echocardiography System Versus Conventional Echo Analyses and Cardiac MRI in Patients Receiving Chemotherapy","AIRES","Inclusion Criteria:\n\n* Aged 18 years or older\n* Received potentially cardiotoxic chemotherapy\n* Participant requires echocardiography surveillance as standard current practice\n\nExclusion Criteria:\n\n* Below the age of 18 years old\n* Inability to give informed consent\n* Implanted cardiac devices\n* Not having received cardiotoxic chemotherapy. Ineligible patients and patients not wishing to take part will be excluded, the reasons for this will be recorded and baseline CONSORT demographics noted including age, gender, ethnicity.",{"count":152,"type":21},120,"To investigate the clinical utility of both 3D and 2D artificial intelligence reconstruction echocardiography (V-echo and L-echo) assessment against conventional echocardiography and clinical cardiovascular magnetic resonance (CMR) imaging for the characterisation of cardiac function and detection of cardiotoxicity in patients receiving chemotherapy.\n\nDiagnostic accuracy of V-echo and L-echo for quantification of cardiac chamber sizes and systolic function (left ventricular ejection fraction (LVEF) and strain analyses) versus conventional echocardiography (C-echo) and CMR; workflow measures including imaging temporal measures of image acquisition, registration and analysis versus conventional approaches; survey of markers of acceptability by patients and sonographers; cost effectiveness analysis of V-echo and L-echo versus conventional echocardiography; assessment of the relationship between 3D strain parameters derived from V-echo data, 2D strain parameters derived from L-echo and correlation with conventional markers of cardiac function, namely LVEF and global longitudinal strain.",[155],"Cardiotoxicity",[157,158,159,160,161],"Echocardiography","Artificial intelligence","Reconstruction","Cardiovascular magnetic resonance (CMR)","Chemotherapy","2026-02-10",{"date":164,"type":30},"2026-02-11",{"date":166,"type":21},"2026-04",{"date":168,"type":21},"2030-11",{"name":36,"class":37},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":38},"100575438","albert-health-app-peg-study-100575438","NCT06772285","Albert Health App PEG Study","Single Arm Feasibility Study of a Digital Health App to Support Adults With Managing a PEG Feeding Tube After Insertion","Albert","Inclusion Criteria:\n\n1. Person ≥18 and\u002For the carer of a person ≥18 having a PEG tube electively inserted; the participant or their supporting carer must be literate in English.\n2. Written informed consent for study participation obtained from the patient or personal consultee (friend\u002Ffamily), with assent as appropriate by the patient, depending on the level of understanding.\n\n   a. Where a personal consultee is the primary participant (ie user of the app) it must be understood that data will be required and collected on the person they are supporting with the app and PEG tube.\n3. Willingness to comply with all study requirements.\n4. The participant or carer must have access to a smart phone or mobile device (such as a pad).\n\nExclusion Criteria:\n\n1. Person being discharged to a nursing home\n2. Both participant and carer are visually impaired.\n3. Patient's whose PEG care will be solely provided by district nurses or professional health care workers\n4. Patient has major surgery scheduled within 7 days of the PEG insertion date",{"count":179,"type":21},50,"Test an existing digital health app, called Albert Health, designed to support patients with a newly inserted feeding tube to use and manage their tube care, in a feasibility study. The feasibility study will evaluate the acceptability, usability and accessibility of the app in preparation for a randomised controlled trial.",[182],"Feeding Tube Complication",[184,185,186,187,188,189,190],"Digital health app","Management","PEG","Feeding tube","Insertion","Albert Health","PEG insertion","2026-01-13",{"date":193,"type":30},"2026-01-15",{"date":195,"type":21},"2026-02",{"date":197,"type":21},"2027-06",{"name":36,"class":37},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":111,"sex":112,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":215,"locationsCount":4},"100559912","prevention-of-retained-items-in-childbirth-environment-and-surgical-sites-100559912","NCT06570304","Prevention of Retained Items iN Childbirth Environment and Surgical Sites","Prevention of Retained Items iN Childbirth Environment and Surgical Sites- Clinical Usability Study","PRINCESS","Inclusion Criteria:\n\n1. Patients due to undergo surgery at the chosen NHS Trust.\n2. Patients 18 years or older and consented to participation after an informed choice.\n\nExclusion Criteria:\n\n1. Under 18 years of age\n2. Emergency surgery",{"count":91,"type":21},"To evaluate the user confidence in the confirmation of correct counts using a novel device and to assess clinical usability of the device during surgery.",[210],"Retained Surgical Items",{"date":193,"type":30},{"date":213,"type":21},"2026-06",{"date":197,"type":21},{"name":36,"class":37},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":226,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":38},"100419400","investigator-initiated-prospective-study-of-xenia-corneal-lenticule-100419400","NCT04741230","Investigator Initiated, Prospective Study of Xenia Corneal Lenticule","Prospective, Investigator Initiated Feasibility Study to Evaluate the Safety, and Indicative Effectiveness of Gebauer™ Lenticules in Patients Suffering From Severe Keratoconus or Post LASIK Ectasia","Inclusion Criteria:\n\n* Diagnosis of severe keratoconus in patients who would prefer to avoid corneal transplant surgery \u002F penetrating keratoplasty OR\n* Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery \u002F penetrating keratoplasty\n* In terms of general health, patients must be free of diagnosed terminal illnesses (life expectancy of greater than or equal to 2 years).\n* Patients must be aged 18 years or over and less than 80 years old\n* Patients' contact lenses must have been removed at least one-week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses\n* Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed\n* Patient must be able and willing to complete all study visits and comply with the study-specific requirements\n\nExclusion Criteria:\n\n* History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems\n* Previous corneal transplantation or corneal implant in the designated eye\n* Cataract with anticipated surgical intervention (IOL implantation) within 2 years\n* Active inflammation and\u002For infection of the eye or the eye lid\n* Patients with Intra Ocular Pressure (IOP) \\\u003C10 mmHg or \\>21 mmHg\n* Professionally diagnosed and currently treated autoimmune diseases\n* Current strong symptoms of any allergy\n* History of major organ transplantation and\u002For current continuing immunosuppressive treatment\n* History of blood transfusion within the last 12 months\n* Subject who is currently participating or has participated in another investigational clinical study within the past 60 days Pregnancy and lactation","79 Years",{"count":225,"type":21},15,"INTERVENTIONAL",[228],"NA","Cornea ectatic conditions such as keratoconus and post-LASIK (Laser In situ Keratomileusis) ectasia are disorders of the eye that are notorious for its uncontrolled progression over time, leading to loss of vision. There are valuable treatment options for controlling disease progression in mild to moderate stages of such disease. However in advanced cases and \u002F or when contact lenses cannot be worn, surgery remains the only treatment option to rehabilitate vision. Most treatment options are highly invasive and represent significant risks. This study evaluates a novel corneal implant, Gebauer™ Lenticule to treat severe keratoconus or post-LASIK ectasia. This implant is derived from porcine collagen and intended for intra-stromal insertion. The Gebauer™ Lenticule is expected to improve the stability of the cornea while not impairing the vision. The procedure is an additive procedure after other treatment options have been exhausted. The procedure is reversible with removal of the implant (in the unexpected case of an adverse reaction), and vision may be restored to baseline.\n\nThe purpose of this study is to evaluate how well the implant is tolerated, it's safety profile, and how effective this new treatment option is in the treatment of keratoconus or post-LASIK ectasia.",[231,232],"Keratoconus","Post-Laser Retinal Condition",{"date":193,"type":30},{"date":235,"type":30},"2024-05-15",{"date":237,"type":21},"2026-12-01",{"name":36,"class":37},""]