[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"i+Med S.Coop.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100627399","clinical-trial-to-evaluate-the-efficacy-and-safety-of-submo-as-a-submucosal-injection-agent-in-endoscopic-resection-of-superficial-gastrointestinal-lesions-100627399",false,"NCT07448129","Clinical Trial to Evaluate the Efficacy and Safety of SUBMO® as a Submucosal Injection Agent in Endoscopic Resection of Superficial Gastrointestinal Lesions.","Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Use of a Medical Device (SUBMO®) for Submucosal Injection in Endoscopic Resection Techniques of Superficial Gastrointestinal Lesions.","Inclusion Criteria:\n\n* Subjects \\>18 years old.\n* Presence of a colorectal lesion larger than 10 mm, confirmed through colonoscopy.\n* The lesion must be considered technically resectable using either Endoscopic Mucosal Resection (RME) or Endoscopic Submucosal Dissection (DSE).\n* The participant must be willing and able to comply with all required study visits and procedures, according to the protocol.\n* The participant must understand, sign, and date the written informed consent form before undergoing any study-specific procedures.\n\nExclusion Criteria:\n\n* Severe comorbidities according to clinical judgment, including patients classified as ASA IV or ASA V, except those ASA IV cases explicitly approved as clinically safe by the center's Anesthesiology Service (using the ASA anesthetic classification).\n* Patients presenting some coagulopathy that prevents safe endoscopic resection.\n* Lesions that are suspicious endoscopic invasive cancer.\n* Any medical condition that, in the investigator's opinion, could compromise patient safety or protocol adherence.\n* Known allergy or hypersensitivity to any component of the investigational product, including hyaluronic acid, methylene blue, or any excipients.\n* Contraindications to colonoscopy or to the administration of sedation\u002Fanesthesia.\n* Current participation in another clinical investigation with an investigational product, or participation in any clinical study (with tested or untested products) within the previous 30 days prior to randomization.\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","The SUBMO-PIC01-2025 study evaluates whether SUBMO®, a submucosal injection hydrogel composed of high-molecular weight hyaluronic acid and methylene blue, is as effective and safe as normal saline for endoscopic resection of superficial colorectal lesions larger than 10 mm. Its primary aim is to determine non-inferiority in complete resection rates, whether en bloc or fragmented, and to assess safety through the systematic identification of serious adverse events. Secondary aims include analysing the total volume of product needed, the number of injections required, the maintenance of the submucosal cushion, the duration of the procedure, the ease of resection, the subjective evaluation of endoscopists, and the appearance of additional adverse events related to the intervention such as intraprocedural bleeding, fever, significant post-procedure pain, post-coagulation syndrome or immediate or delayed perforation.\n\nEligible participants are adults aged 18 or older with a confirmed colorectal lesion greater than 10 mm that is technically resectable using EMR or ESD, who are capable and willing to follow the study procedures and who have signed informed consent prior to any protocol-specific action. Exclusion criteria include severe comorbidities corresponding to ASA IV or V unless specifically authorised by anaesthesia, coagulopathies that prevent endoscopic resection, endoscopic suspicion of invasive cancer, any condition deemed by investigators to compromise safety or adherence, known allergy to hyaluronic acid, methylene blue or excipients, contraindications to colonoscopy or sedation, participation in another clinical investigation within the previous 30 days, and pregnancy or breastfeeding. Participants may be withdrawn due to voluntary consent withdrawal, safety concerns, protocol deviations that affect data integrity or patient safety, loss to follow-up or pregnancy discovered during the study.\n\nThe main efficacy variable is the technical success of resection as judged immediately by the endoscopist, while the main safety variable is the incidence of serious adverse events and their causal relationship with the investigational product. Exploratory variables include baseline demographics such as age, sex, ethnic origin and body mass index, anticoagulant or antiplatelet medication, and comorbidities including endoscopic history, obesity, hypertension, cardiovascular disease, haematologic disorders such as von Willebrand disease or haemophilia, and chronic liver disease. Baseline variables also include ASA classification and lifestyle habits. Polyp-related variables include size, number, anatomical location in the colon or rectum, LST subtype and JNET classification. Resection-related variables capture the technique used (EMR or ESD), whether the resection is en bloc or piecemeal, the number of fragments for calculating the Sydney Resection Quotient, the DMI score and any closure technique or complications. Treatment-related variables include total and per-surface area injection volume, number of submucosal injections needed, macroscopic evaluation of cushion maintenance, total procedure time, ease of resection using a visual analogue scale from 0 to 100, a usability questionnaire completed by the endoscopists and a detailed record of all adverse events including bleeding, fever, pain, post-coagulation syndrome and perforation.",[26],"Colorectal Polyps",[28,29,30],"Submucosal injection","endoscopic resection","hyaluronic acid hydrogel","NOT_YET_RECRUITING","2026-03-03",{"date":34,"type":35},"2026-03-05","ACTUAL",{"date":37,"type":20},"2026-03",{"date":39,"type":20},"2027-03",{"name":41,"class":42},"i+Med S.Coop.","INDUSTRY",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100626861","efficacy-and-safety-of-bth-body-22-injectable-hyaluronic-acid-in-volumizing-and-contouring-large-areas-of-the-body-prospective-clinical-investigation-100626861","NCT07441135","Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.","Inclusion Criteria:\n\n* Adults (≥18 years old)\n* Presence of extensive body areas (gluteal region, thighs, or abdomen) showing aesthetic concerns such as:\n* loss of volume\n* flaccidity\n* contour asymmetries\n* skin irregularities\n* cellulite\n* Willingness and ability to comply with all study visits and procedures.\n* Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires.\n* Negative urine pregnancy test for women of childbearing potential at required visits.\n* Use of appropriate contraception for women of childbearing potential, as outlined in the protocol.\n\nExclusion Criteria:\n\n* Allergy or sensitivity to any of the components of the investigational product.\n* Planned pregnancy or breastfeeding.\n* Presence of active pathology or bacterial, fungal, or viral infection in or near the area to be treated, or undergoing active treatment for these conditions\n* Presence of clinical signs of inflammation in or near the area of interest or undergoing active treatment for these conditions.\n* Individuals with a known tendency to develop hypertrophic scars or keloids.\n* Individuals undergoing anticoagulant therapy.\n* Presence of volumetric defects that are too large and require surgical procedures, in the opinion of the healthcare specialist.\n* Subjects who have undergone any interventional cosmetic procedure in the 6 months prior to entering the study or during the study, such as laser, radiofrequency, electrotherapy, intradermal fillers, lipotransfer, thread lifts, platelet-rich plasma, among others.\n* Subjects with disproportionate expectations regarding the expected results of treatment.\n* Subjects with any of the following contraindications: Chronic conditions (Active autoimmune diseases (or under immunosuppressive treatment): Systemic lupus erythematosus, scleroderma, active rheumatoid arthritis, or Sjögren's syndrome; Active infections or inflammatory processes in the area of application: Herpes simplex, pustular acne, folliculitis, or cellulitis; Uncontrolled coagulation disorders or use of anticoagulants; Immunocompromised patients (due to disease or treatment): Uncontrolled HIV, chemotherapy, systemic corticosteroids, or organ transplantation) and medications (medications that increase the risk of bleeding or bruising: anticoagulants (warfarin or acenocoumarol) and antiplatelet agents (salicylic acid, prasugrel, or ticagrelor), immunosuppressants and biologics (prolonged systemic corticosteroids such as methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, biologic drugs such as infliximab or adalimumab), systemic retinoids (isotretinoin), antidepressants, oral antidiabetics\u002Finsulin)",{"count":51,"type":20},80,[23],"This clinical investigation is a prospective, interventional, single-center study designed to assess the safety and effectiveness of BtH Body 2.2%, a cross-linked hyaluronic acid injectable intended for aesthetic volumization and contouring of large body areas. The study enrolls 80 adult participants who seek aesthetic improvement in the gluteal region, thighs, or abdomen. Each participant will receive a single session of subcutaneous injections, with the option for a touch-up treatment at four weeks if clinically justified, and will be followed for a total of nine months.\n\nThe primary aim of the study is to determine whether BtH Body 2.2% produces a clinically relevant improvement in the treated area, assessed by the Global Aesthetic Improvement Scale (GAIS), and to evaluate the safety profile of the product by monitoring the incidence of serious adverse events throughout the study period. Secondary assessments will examine patient satisfaction, investigator-rated changes in aesthetic parameters such as volume, firmness, uniformity, elasticity, and overall appearance, as well as improvements in quality of life using validated questionnaires, including the Body Self-Esteem Scale and the Patient Global Impression of Improvement (PGI-I). Objective measurements of skin hydration, elasticity, firmness, and topography will also be obtained using specialized biometric devices.\n\nThe overall goal is to generate robust clinical evidence supporting the use of BtH Body 2.2% for safe and effective body contouring and volumization.",[55],"Aesthetic Body Volume Loss",[57,58,59,60],"Hyaluronic Acid","Body Contouring","Soft-Tissue Augmentation","Aesthetic Enhancement","2026-02-25",{"date":63,"type":35},"2026-02-27",{"date":65,"type":20},"2026-02",{"date":67,"type":20},"2027-01",{"name":41,"class":42},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":69},"100624170","efficacy-and-safety-of-zkare-gel-and-its-accessory-zkapi-in-the-treatment-of-chronic-ulcers-100624170","NCT07406152","Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.","Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers: a Prospective, Randomized, Controlled Clinical Investigation.","Inclusion Criteria:\n\n* Adult patients (≥18 years).\n* Presence of at least one chronic hard-to-heal ulcer, including any of the following etiologies: Grade II, III or IV pressure ulcers; neuropathic diabetic foot ulcers (grade I, II or III), Wagner Grade I-III or Texas 0, I, II, III \u002F Stage B; class C6\u002FC6r venous leg ulcers measured with CEAP scale ; neuro-ischaemic ulcers with adequate distal perfusion (ABI\u002FITB ≥ 0.7-0.89; mild PAD); mixed-etiology venous ulcers and any chronic lower-limb lesion with palpable distal pulses.\n* Ulcer size between 1 cm² and 100 cm².\n* Ability and willingness to comply with all study visits and procedures according to the clinical protocol.\n* Ability to understand and sign the informed consent, obtained before performing any protocol-specific procedures.\n\nExclusion Criteria:\n\n* Ulcers of etiologies not listed in the inclusion criteria.\n* Ischaemic, neoplastic or atypical ulcers.\n* Severe comorbidities judged to compromise safety or study compliance, including: severe malnutrition, palliative\u002Fterminal status, severe anemia, decompensated heart failure, chronic kidney disease stage III\u002FIV or in dialysis.\n* Ulcers with moderate-severe or severe infection per PEDIS-IDSA infection grading scale.\n* Known allergy or sensitivity to any component of the investigational product.\n* Any condition that, in the investigator's opinion, may compromise patient safety or adherence to the protocol.\n* Pregnancy or planned breastfeeding.",{"count":78,"type":20},134,[23],"This prospective, randomized, single-blind, controlled clinical investigation evaluates the efficacy and safety of ZKARE®, a topical polymeric gel dressing, and its accessory applicator ZKAPI®, for the treatment of chronic, hard-to-heal ulcers. The study includes 134 ulcers of different etiologies-pressure ulcers, neuropathic diabetic foot ulcers, and venous leg ulcers-meeting predefined selection criteria. Participants are randomized to receive either ZKARE® in addition to standard wound care or standard care alone.\n\nThe primary efficacy endpoint is the change in wound condition assessed through the RESVECH 2.0 scale, recorded at baseline and throughout treatment and follow-up visits. The primary safety endpoint is the incidence of serious adverse events (SAEs). Secondary outcomes include percentage and rate of wound closure, total closure rate, estimated time to full closure, quality-of-life measures (DLQI), patient satisfaction, investigator global assessment, cost-effectiveness, and product usability. The study aims to generate evidence on the performance, safety, and clinical usefulness of ZKARE® for chronic wound management.",[82],"Chronic Ulcers",[84,85,86,87,88],"Pressure ulcers","Hyaluronic acid","Wound healing","Topical gel","venous leg ulcers","RECRUITING","2026-02-17",{"date":92,"type":35},"2026-02-19",{"date":94,"type":35},"2025-11-14",{"date":96,"type":20},"2026-07",{"name":41,"class":42},""]