[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06660758":3,"trial-entities:NCT06660758":77,"trial-summary:NCT06660758":81},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":16,"healthy_volunteers":41,"eligibility_criteria":42,"std_ages":46,"locations":49,"central_contacts":70,"overall_officials":73,"references":75,"see_also_links":76},"NCT06660758","CRD-04-1934-01","Pilot Study of the Entarik System With Advanced Functionality in Health Adults","RECRUITING","2025-12-22","2025-07","2025-07-11","2024-10-22","Gravitas Medical, Inc.","INDUSTRY",false,"In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.",null,[18],"Healthy Adults",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},40,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Feeding tube (Entarik)","Feeding tube placement will be verified using multiple methods in the duodenum and stomach.",[18],[34],{"measure":35,"description":36,"timeFrame":37},"Freedom from device-related adverse events","The incidence and severity of Adverse Events (AEs) including device and procedure-related AEs and the incidence and severity of Serious Adverse Events (SAEs) will be evaluated throughout the study.\n\nBased on the non-invasive nature of the device and clinical experience gained to date, there are expected to be no SAEs nor Unanticipated Adverse Device Effects (UADEs) in the study. If any SAEs or UADEs occur they will be documented and reported, but there are no planned formal hypotheses associated with the evaluation of safety.","From enrollment to end of study (1 day)",[],"ALL","18 Years",true,{"inclusion":43,"exclusion":44,"raw_text":45},[],[],"Inclusion Criteria:\n\n1. At least 18 years old\n2. Able to provide informed consent\n3. Capable and willing to follow all study-related procedures\n4. Confirmed fasted state for a minimum of 8 hours prior to study initiation\n\nExclusion Criteria:\n\n1. Inability to receive a feeding tube\n2. Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers\n3. Has a basilar skull fracture\n4. Self-reports pregnancy\n5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination",[47,48],"ADULT","OLDER_ADULT",[50],{"facility":12,"status":7,"city":51,"state":52,"zip":53,"country":54,"contacts":55,"geoPoint":67},"Berkeley","California","94710","United States",[56,61,64],{"name":57,"role":58,"phone":59,"email":60},"Aaron Miller","CONTACT","415-926-8616","clinicalstudy@theranova.com",{"name":62,"role":63},"Thomas Sorrentino, MD","PRINCIPAL_INVESTIGATOR",{"name":65,"role":66},"Daniel Burnett, MD","SUB_INVESTIGATOR",{"lat":68,"lon":69},37.87159,-122.27275,[71],{"name":72,"role":58,"phone":59,"email":60},"Director of Clinical",[74],{"name":62,"role":63},[],[],{"nct_id":4,"conditions":78,"biomarkers":80},[79],"Healthy",[],{"nct_id":4,"found":41,"summary":82,"prompt_version":92},{"design":83,"status":84,"heading":85,"summary":86,"follow_up":87,"word_count":88,"commitments":89,"compensation":90,"drugs_mentioned":91},"This is an interventional study involving 40 healthy adult participants. It is a single-site study, meaning it takes place at one location.","completed","Pilot Study of the Entarik System in Healthy Adults","This study is testing a new feeding tube called the Entarik System. Researchers want to see if the Entarik System can be placed and removed safely in healthy adults. You might be able to join if you are at least 18 years old, can give informed consent, and have fasted for at least 8 hours. The main goal is to make sure there are no problems related to the device during the study, which lasts one day. The study is currently recruiting 40 healthy adults.","You will be followed from enrollment until the end of the study, which is one day.",85,"You would have the Entarik feeding tube placed and removed. Researchers will also collect data before, during, and after you receive a meal through the tube.","Not stated in the trial record.",[],"v2"]