[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"DJO UK Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":155},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,74,96,129],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100578283","observational-prospective-pmcf-study-to-confirm-performance-and-safety-of-intelect-devices-in-real-world-100578283",false,"NCT06809283","Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World","Observational Prospective Post Market Clinical Follow-up (PMCF) Study to Confirm the Performance and Safety of the Chattanooga Intelect® Devices in Real World Use","INTELECT","Inclusion Criteria:\n\n1. Patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the Intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the Investigator.\n2. Patient male or female with age ≥18 years old.\n3. Patient able to provide written informed consent. For France only: To be affiliated to the social security system or to be beneficiary of such system\n\nExclusion Criteria:\n\n1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment.\n2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.","ALL","18 Years",{"count":20,"type":21},144,"ESTIMATED","OBSERVATIONAL","DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).",[25,26,27],"Musculoskeletal Disorders","Skeletal Disorder","Muscle Disorder",[29,30,31,32,33],"TENS","NMES","Ultrasound","Pain","ROM","RECRUITING","2025-11-14",{"date":37,"type":38},"2025-11-17","ACTUAL",{"date":40,"type":38},"2025-03-10",{"date":42,"type":21},"2026-12",{"name":44,"class":45},"DJO UK Ltd","INDUSTRY",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100581723","performance-and-safety-of-lightforce-therapy-lasers-on-lateral-ankle-sprain-100581723","NCT06854016","Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain","Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Lateral Ankle Sprain Pain Reduction","BRIGHT","Inclusion Criteria:\n\n1. Patient male or female with age ≥18 years old\n2. Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.\n3. Patient suffering from LAS pain for no more than 72 hours prior to enrollment\n4. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS\n5. Patient able to provide written informed consent\n\nExclusion Criteria:\n\n1. Patient with musculoskeletal pathological conditions not to be treated with\u002Fcontraindication to the use of LightForce® Therapy Lasers according to its intended use and indications\n2. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids\n3. Patients who have been administered with corticosteroids after injury\n4. Pregnant females or females of childbearing potentially planning to become pregnant during the study participation\n5. Patients who had systemic inflammatory conditions (i.e. rheumatoid arthritis, polymyalgia rheumatica)\n6. Patients affected by chronic ankle instability (recurrent sprains, ankle instability, functional ankle instability, mechanical ankle instability fol¬lowing the first-time injury)\n7. Patients with bilateral ankle sprain\n8. Patients who have a disease that would limit their participation in exercises (i.e. severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascular event history)\n9. Patients with fractures (as confirmed by radiological examination)\n10. Patients with a diagnosis of active cancer\n11. Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers\n12. Patients who are mentally or physically incapacitated\n13. Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment\n14. Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator",{"count":56,"type":21},108,"INTERVENTIONAL",[59],"NA","DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and\u002For sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy\u002Fexercise program, compared to sham laser combined with standard of care (RICE and physiotherapy\u002Fexercise program) on pain reduction in subjects with acute grade I - II lateral ankle sprain. In addition, this study allows to collect post market clinical data on the safety and performance of LightForce® Therapy Lasers, when used, following the normal clinical practice, in accordance with its approved and CE marked intended use.",[62,63,64],"Ankle Sprain 1St Degree","Ankle Sprain 2Nd Degree","Acute Pain",[66],"lateral acute grade I and II ankle sprain, pain, laser",{"date":37,"type":38},{"date":69,"type":38},"2025-04-11",{"date":71,"type":21},"2026-09",{"name":44,"class":45},8,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":57,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":94,"locationsCount":95},"100574488","performance-and-safety-of-lightforce-therapy-lasers-on-shoulder-soft-tissue-inflammation-pain-reduction-100574488","NCT06759935","Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction","Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction","SHINE","Inclusion Criteria:\n\n1. Patient male or female with age ≥18 years old\n2. Patient with diagnosis of shoulder soft tissue inflammation due to SAIS\u002FRCT (as confirmed by physical examination and\u002For imaging) to be treated by LightForce® Therapy Lasers according to its indications.\n3. Patient suffering from shoulder soft tissue inflammation due to SAIS\u002FRCT pain for more than 3 months prior to enrollment\n4. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS\n5. Patient able to provide written informed consent\n\nExclusion Criteria:\n\n1. Patient with musculoskeletal pathological conditions not to be treated with\u002Fcontraindication to the use of LightForce® Therapy Lasers according to its intended use and indications\n2. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids\n3. Patients who are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start\n4. Pregnant females or females of childbearing potentially planning to become pregnant during the study participation\n5. Patients who had systemic inflammatory conditions (i.e.rheumatoid arthritis, polymyalgia rheumatica)\n6. Patients who underwent intra-articular injection (Ialuronic acid, platelet rich plasma or corticosteroids) in the shoulder in the last 3 months\n7. Patients who have a disease that would limit their participation in exercises (i.e. severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascular event history)\n8. Patients with a prior history of surgical intervention and implantation of a metal implant into the affected shoulder\n9. Patients with a diagnosis of active cancer\n10. Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers\n11. Patients who are mentally or physically incapacitated\n12. Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment\n13. Patient affected by shoulder soft tissue acute inflammation due to recent sport injury or trauma\n14. Patients with other musculoskeletal problems of the shoulder joint such as calcifying tendinitis, full thickness rotator-cuff tear, adhesive capsulitis, fibromyalgia, recent surgery or fracture of the shoulder joint, and\u002For undergoing to specific physiotherapy for these (\"recent\" is defined as within 30 days prior to enrollment).\n15. Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator",{"count":83,"type":21},130,[59],"DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in shoulder soft tissue inflammation. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by physiotherapy\u002Fexercise program compared to sham laser combined with standard of care (physiotherapy\u002Fexercise program) on pain reduction in subjects with shoulder soft tissue inflammation due to Impingement (Subacromial impingement syndrome (SAIS)) or Rotator Cuff Tendinopathy (RCT),. In addition, this study allows to collect post market clinical data on the safety and performance of LightForce® Therapy Lasers, when used, following the normal clinical practice, in accordance with its approved and CE marked intended use.",[87,88,89],"Shoulder Pain","Shoulder Impingement Syndrome","Rotator Cuff Tendinitis",{"date":37,"type":38},{"date":92,"type":38},"2025-02-21",{"date":42,"type":21},{"name":44,"class":45},10,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":57,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100571249","compex-sp80---symptomatic-treatment-of-musculoskeletal-pain-100571249","NCT06717789","Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain","Post-Market Prospective Clinical Follow Up Study on the Symptomatic Treatment of Musculoskeletal Pain Through Sensory Nerve Stimulation Using the Compex SP8.0 Device","Inclusion Criteria:\n\n1. Adult subjects currently experiencing musculoskeletal pain with a Numeric Pain Rating Scale (NPRS) score of 4 or more at baseline.\n2. Subjects are considered suitable to self-administer stimulation of motor nerves or stimulation of sensory nerves at home, based on the Investigator's judgement.\n3. Subjects are suitable to receive treatment using the Compex SP8.0 device Pain management programs (pre-set parameters) for up to 4 weeks, based on the Investigator's judgement.\n4. Subject, both male and female, ≥ 18 years of age at the time of consent\n5. Subject has reviewed the IEC-approved consent form, has properly consented per the protocol and has documented their consent to participate in the study by signing the Ethics-approved consent form.\n6. Subject does not meet any of the exclusion criteria\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Presence of Implanted electronic devices (e.g., pacemakers, defibrillators)\n3. Skin conditions that contraindicate TENS use (e.g., rashes, wounds in electrode placement areas).\n4. Known allergy to electrode materials.\n5. Current participation in another clinical study that could interfere with this study's outcomes.\n6. Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers\n7. Subjects who are not able to read and understand indications and contraindications of the device\n8. Subjects who are not able to sense auditory and visual signals\n9. Subjects who are being treated with any other electrotherapy device for pain relief.\n10. Subjects who are being treated with acupuncture\n11. Participation in another clinical study within 30 days prior to screening",{"count":104,"type":21},74,[59],"This post-market clinical study of the SP8.0 Compex device aims to comprehensively assess the safety and performance of the device when used in accordance with the approved Instructions for Use. The results of this study will also support the clinical evaluation of the next-generation wireless product currently under development.\n\nThe Compex Consumer devices contain different programs, such as conditioning, fitness, recovery, massage, rehabilitation, and pain management.\n\nThis study will utilize the Compex SP 8.0 pain management programs, with the aim of assessing the effectiveness of the treatment provided by the device in managing pain through different physiological mechanisms.",[108,109],"Musculoskeletal Conditions","Musculoskeletal Pain",[111,112,113,114,115,116,117,118],"Electrostimulation","Transcutaneous Electrical Nerve Stimulation (TENS)","Stimulation of sensory nerves","Compex SP8.0","Gate control principle","Endorphinic TENS","Low Frequency TENS","High Frequency TENS","NOT_YET_RECRUITING","2025-02-05",{"date":122,"type":38},"2025-02-06",{"date":124,"type":21},"2025-02",{"date":126,"type":21},"2025-09",{"name":44,"class":45},2,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":57,"phases":138,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},"100566773","cefar-uro---symptomatic-treatment-of-overactive-bladder-100566773","NCT06659536","Cefar URO - Symptomatic Treatment of Overactive Bladder","Post-market Prospective Clinical Investigation on the Symptomatic Treatment of Urge Incontinence in Adults With Overactive Bladder With Cefar URO","Inclusion Criteria:\n\n* Adult patients with overactive bladder (including refractory overactive bladder of idiopathic or neurogenic origin) who require symptomatic treatment of urge incontinence and associated symptoms.\n* Subjects, both male and female, ≥ 18 years of age at the time of consent\n* Subjects have provided their written consent to participate in the study by signing the Ethics-approved consent form.\n* Patients are considered able and willing to self-administer transcutaneous tibial nerve stimulator (TTNS) treatment at home, based on Investigator's judgement.\n* Patients are suitable to receive treatment using the Cefar URO device P4 program pre-set parameters (frequency 20Hz and pulse width 200μs) for 12 weeks, based on Investigator's judgement.\n* If undergoing pharmacological therapy for incontinence, the therapy must be stabilized for at least 4 weeks before baseline visit\n\nExclusion Criteria:\n\n* Pregnancy confirmed by urine test at screening\n* Urinary tract infection confirmed by urine analysis\n* Serious secondary illness (such as renal failure, nephrolithiasis, bladder and kidney tumors)\n* Detrusor-sphincter dyssynergia\n* Patients who have or have had implantable neurostimulating cardiac demand pacemakers, ICD; or other implantable electronic devices\n* Subjects who are not able to read and understand the Instructions for Use, warnings, cautions and dangers\n* Subjects who are not able to read and understand indications and contraindications of the device\n* Subjects who are not able to sense auditory and visual signals\n* Patients with anti-incontinence surgery planned during the course of the study\n* Participation in another clinical study within 30 days prior to screening",{"count":137,"type":21},53,[59],"A Post-Market Prospective Clinical Investigation to collect PMCF data on the safety and performance of the Cefar URO device when using the preset program P4 (parameter setting: frequency 20Hz, pulse width 200μs) for the symptomatic treatment of urge incontinence in adults with overactive bladder in accordance with the approved labelling.\n\nThe Cefar URO device features four pre-set programs (P1, P2, P3 and P4) and three custom programs. Although supporting data on the preset programs P1, P2, P3 are available for the clinically equivalent UROstim2 device, program P4 is unique to Cefar URO. Program P4 utilizes the parameters 20Hz and 200μs which are commonly reported in the literature for the stated indications but for which no data is available for the clinically equivalent UROstim2 device. The present study is therefore aimed to cover this data gap.",[141,142,143],"Overactive Bladder (OAB)","Refractory Overactive Bladder","Urinary Urgency and Frequency",[145,141,146,147],"Urinary urgency","Transcutaneous Tibial Nerve Stimulation (TTNS)","Cefar Uro",{"date":122,"type":38},{"date":150,"type":21},"2025-03",{"date":152,"type":21},"2026-03",{"name":44,"class":45},1,""]