[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07194395":3,"trial-entities:NCT07194395":115,"trial-summary:NCT07194395":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":48,"sex":59,"minimum_age":60,"maximum_age":28,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":103,"overall_officials":112,"references":113,"see_also_links":114},"NCT07194395","CMAP-001","Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients","A Prospective International Multicenter, Non-Interventional, Single Arm, Blinded Feasibility Study to Assess the Contactless Optical Monitoring of AV Access Using the PatenSee System in Dialysis Patients","RECRUITING","2027-02-28","2025-09","2025-09-26","2025-06-06","PatenSee Ltd.","INDUSTRY",false,"This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or graft) will be recruited and evaluated using the PatenSee system.\n\nData captured on the PatenSee system will be analyzed and evaluated against standard of care clinical monitoring of AV accesses.","For eligible participants, a clinical exam of the AV access (\"Look, Listen, Feel\") per SOC will be done by a qualified site clinician\u002Fnurse, followed by an assessment of the AV access using the PatenSee system on a weekly basis for 6 weeks, and then biweekly up to 1 year from enrollment. Additional data regarding imaging and complications of the AV access will be collected. Clinical decisions, such as referrals for further investigation and management of the AV access will be based solely on standard clinical monitoring.",[19,20],"Hemodialysis","Clinical Assessment",[22,23,24,25,26],"Nephrology","AV access","Clinical monitoring of AV access","Fistula","AV graft","OBSERVATIONAL",null,[],{"count":31,"type":32},90,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","PatenSee System","Contactless AV access monitoring device",[39],"AVF\u002FG access",[41,45],{"measure":42,"description":43,"timeFrame":44},"Comparison of \"Look\" assessment with PatenSee's relevant output","Agreement between the ability to detect AV access structure parameters by PatenSee's images and the ability to detect the same parameters by clinical monitoring","6 weeks per patient",{"measure":46,"description":47,"timeFrame":44},"Comparison of \"Listen & Feel\" assessments with PatenSee's relevant output","Agreement between the PatenSee audio analysis of the AV access bruit and the sound recording of the AV access using a standard digital stethoscope measured",[49,53,56],{"measure":50,"description":51,"timeFrame":52},"Functionality endpoint - Average time to conduct PatenSee scanning data capture","Average time to conduct PatenSee scanning data capture","Up to 12 months",{"measure":54,"description":55,"timeFrame":52},"Functionality endpoint - Proportion (%) of participants on whom the PatenSee was used as planned","Proportion (%) of participants on whom the PatenSee was used as planned",{"measure":57,"description":58,"timeFrame":52},"Functionality endpoint - Average number of weeks participants obtained PatenSee measurements","Average number of weeks participants obtained PatenSee measurements","ALL","18 Years",{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Male and female adult patient aged ≥18 years old\n2. Patient has a non-reversible kidney failure that requires long-term hemodialysis\n3. Patient has a functioning AV access (AVF\u002FG) in the upper extremity\n4. Patient is able and willing to provide consent by signing an EC\u002FIRB approved informed consent form\n5. Patient is willing and able to follow the requirements of the study\n\nExclusion Criteria:\n\n1. An active AV access infection\n2. An AV access condition that will likely require revision, e.g., symptomatic steal syndrome\n3. Expected to recover kidney function, receive a kidney transplant, transfer to peritoneal dialysis (PD) or transfer to non-study site during the study period.\n4. Any reason per investigator's discretion for which the patient is not suitable for the study\n5. Any medical or psychiatric illness, which in the opinion of the investigator would compromise the patient's ability to adhere to study requirements\n6. Previous participation in an interventional study within 30 days prior to study enrollment that may interfere with evaluation of the study endpoints\n7. Female patient is pregnant or breastfeeding",[66,67],"ADULT","OLDER_ADULT",[69,86],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":83},"Henry Ford Hospital","Detroit","Michigan","48202","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Lalathaksha Kumbar, MD","CONTACT","3139162711","lkumbar1@hfhs.org",{"name":77,"role":82},"PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},42.33143,-83.04575,{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":100},"Meir Medical Center","NOT_YET_RECRUITING","Kfar Saba","Hasharon","4428164","Israel",[94,98],{"name":95,"role":78,"phone":96,"email":97},"Site contact","+97297471889","mekerenben@clalit.org.il",{"name":99,"role":82},"Irina Kenis, MD",{"lat":101,"lon":102},32.175,34.90694,[104,108],{"name":105,"role":78,"phone":106,"email":107},"Naama Barel","972-508341678","Naama.b@patensee.com",{"name":109,"role":78,"phone":110,"email":111},"Adi Bigger Hoggeg","972-544708066","Adi.h@patensee.com",[],[],[],{"nct_id":4,"conditions":116,"biomarkers":120},[117,118,119],"Arteriovenous Fistula","Arteriovenous graft","Renal Failure",[],{"nct_id":4,"found":122,"summary":123,"prompt_version":133},true,{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an observational study, meaning it watches what happens without giving new treatments. It plans to include 90 participants.","completed","Contactless Monitoring of AV Access in Hemodialysis Patients","This study is looking at a new device called the PatenSee System, which monitors your AV access (the connection made for hemodialysis) without touching it. We want to see how well the PatenSee System's results compare to the usual ways doctors check your AV access, which involve looking, listening, and feeling it. You might be able to join if you are an adult (18 or older) with kidney failure who needs regular hemodialysis and has a working AV access in your arm. The study aims to enroll 90 people. We will compare the PatenSee System's readings with your doctor's assessments over 6 weeks to see if it provides similar information.","Participants will be assessed biweekly for up to one year from enrollment.",110,"You would have a standard clinical exam of your AV access, followed by weekly assessments with the PatenSee System for 6 weeks, and then every two weeks for up to one year.","Not stated in the trial record.",[36],"v2"]