[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07649720":3,"trial-entities:NCT07649720":117,"trial-summary:NCT07649720":122},{"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":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":69,"locations":72,"central_contacts":88,"overall_officials":93,"references":96,"see_also_links":116},"NCT07649720","P11_CEP-0001","NaviCam Patency Capsule to Verify Gastrointestinal Patency","A Prospective, Single Center Clinical Trial Assessing the Efficacy and Safety of the NaviCam Patency Capsule to Verify Gastrointestinal Patency","NOT_YET_RECRUITING","2027-03-15","2026-06","2026-06-16","2026-06-15","AnX Robotica Corp.","INDUSTRY",false,"Participants included in this study will first swallow a patency capsule and then undergo an abdominal X-ray scan within 30 hours after swallowing the capsule to confirm weather the capsule is still in the body.","If the X-ray scan indicates that the capsule is not in the body or shows that the patency capsule is in the colonic area or if an intact patency capsule is found in the bowel movement, it proves that the intestine is patent, and the patient can undergo an examination using capsule endoscopy. If the X-ray scan shows that the capsule is still in the small bowel area, it indicates that there may be stricture(s) in the intestines, and then small bowel capsule endoscopy may not be performed.\n\nThe patency capsule is a disposable medical device composed of medicinal excipients in the shape of a dissolvable passive capsule and will dissolve over time if not excreted.",[19,20,21,22],"Intestinal Stricture","Crohn Disease","NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy","Abdominal Pain",[],"INTERVENTIONAL","SCREENING",[27],"NA",{"count":29,"type":30},25,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","NaviCam Patency Capsule","The NaviCam Patency Capsule is an accessory to the NaviCam capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the NaviCam capsule in patients with known or suspected strictures.",[37],"Single arm patency capsule evaluation",[39,43],{"measure":40,"description":41,"timeFrame":42},"Safety of patency capsule","The number of patients successfully passing the Patency Capsule within 30 hours compared to the number of patients where the Patency Capsule dissolves in patients with strictures.","30 hours",{"measure":44,"description":45,"timeFrame":42},"Efficacy of patency capsule","The percentage of patients that successfully pass the Patency capsule within 30 hours.",[],"ALL","22 Years",null,{"inclusion":51,"exclusion":60,"raw_text":68},[52,53,54,55,56,57,58,59],"Patients with suspected or known intestinal stricture (with medical history records, physical examination records, and imaging evidence within the last 6 months.","Patients suffering from Crohn's Disease","Patients with long-term use of non-steroidal anti-inflammatory drugs.","Patients with abdominal symptoms related to intestinal stricture.","Patients with chronic inflammatory diseases.","Patients with difficulty with balloon-assisted endoscopy (BAE).","Patients with a history of small bowel obstruction.","Patients with a history of intestinal resection surgery.",[61,62,63,64,65,66,67],"Patients with esophageal obstruction or swallowing disorder diseases.","Patients who are ineligible for surgery or refuse to undergo any abdominal surgery.","Patients with known allergies or other contraindications or intolerance to the medications used in this study.","Patients with pacemakers or other implanted electronic devices such as cochlear implants, magnetic metal drug infusion pumps, neurostimulators.","Pregnant women","Patients currently enrolled in another drug or device clinical trial.","Other conditions deemed unsuitable for inclusion by the investigator.","Inclusion Criteria:\n\n* Patients with suspected or known intestinal stricture (with medical history records, physical examination records, and imaging evidence within the last 6 months.\n* Patients suffering from Crohn's Disease\n* Patients with long-term use of non-steroidal anti-inflammatory drugs.\n* Patients with abdominal symptoms related to intestinal stricture.\n* Patients with chronic inflammatory diseases.\n* Patients with difficulty with balloon-assisted endoscopy (BAE).\n* Patients with a history of small bowel obstruction.\n* Patients with a history of intestinal resection surgery.\n\nExclusion Criteria:\n\n* Patients with esophageal obstruction or swallowing disorder diseases.\n* Patients who are ineligible for surgery or refuse to undergo any abdominal surgery.\n* Patients with known allergies or other contraindications or intolerance to the medications used in this study.\n* Patients with pacemakers or other implanted electronic devices such as cochlear implants, magnetic metal drug infusion pumps, neurostimulators.\n* Pregnant women\n* Patients currently enrolled in another drug or device clinical trial.\n* Other conditions deemed unsuitable for inclusion by the investigator.",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"Digestive Health Services","Downers Grove","Illinois","60515","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Rockford G Yapp, MD","CONTACT","630-297-9474","rockford.g.yapp3@gmail.com",{"lat":86,"lon":87},41.80892,-88.01117,[89],{"name":90,"role":82,"phone":91,"email":92},"Tim Thomas, RAC","770-480-2911","tim.thomas@anxrobotics.com",[94],{"name":81,"affiliation":74,"role":95},"PRINCIPAL_INVESTIGATOR",[97,101,104,107,110,113],{"pmid":98,"type":99,"citation":100},"31915319","BACKGROUND","Takeda K, Tashimo H, Miyakawa K, Shimada M, Ohshima N, Tamura A, Nagai H, Matsui H. Patency Capsule Aspiration. Intern Med. 2020 Apr 15;59(8):1071-1073. doi: 10.2169\u002Finternalmedicine.4012-19. Epub 2020 Jan 9.",{"pmid":102,"type":99,"citation":103},"24698874","Okoli A, Ammannagari N, Mazumder M, Nakkala K. When the dissolvable does not dissolve: an agile patency capsule mystery. Am J Gastroenterol. 2014 Apr;109(4):605-7. doi: 10.1038\u002Fajg.2013.435. No abstract available.",{"pmid":105,"type":99,"citation":106},"29718225","Mitselos IV, Katsanos K, Tsianos EV, Eliakim R, Christodoulou D. Clinical Use of Patency Capsule: A Comprehensive Review of the Literature. Inflamm Bowel Dis. 2018 Oct 12;24(11):2339-2347. doi: 10.1093\u002Fibd\u002Fizy152.",{"pmid":108,"type":99,"citation":109},"17577114","Spada C, Shah SK, Riccioni ME, Spera G, Marchese M, Iacopini F, Familiari P, Costamagna G. Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule. J Clin Gastroenterol. 2007 Jul;41(6):576-82. doi: 10.1097\u002F01.mcg.0000225633.14663.64.",{"pmid":111,"type":99,"citation":112},"18355824","Herrerias JM, Leighton JA, Costamagna G, Infantolino A, Eliakim R, Fischer D, Rubin DT, Manten HD, Scapa E, Morgan DR, Bergwerk AJ, Koslowsky B, Adler SN. Agile patency system eliminates risk of capsule retention in patients with known intestinal strictures who undergo capsule endoscopy. Gastrointest Endosc. 2008 May;67(6):902-9. doi: 10.1016\u002Fj.gie.2007.10.063. Epub 2008 Mar 19.",{"pmid":114,"type":99,"citation":115},"27652302","Kopylov U, Nemeth A, Cebrian A, Wurm Johansson G, Thorlacius H, Fernandez-Urien Sainz I, Koulaouzidis A, Eliakim R, Toth E. Symptomatic retention of the patency capsule: a multicenter real life case series. Endosc Int Open. 2016 Sep;4(9):E964-9. doi: 10.1055\u002Fs-0042-112588. Epub 2016 Aug 8.",[],{"nct_id":4,"conditions":118,"biomarkers":121},[119,20,19,120],"Chronic inflammatory disorder","NSAID-Induced Nephropathy",[],{"nct_id":4,"found":123,"summary":124,"prompt_version":134},true,{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study with a planned enrollment of 25 participants. The study does not specify a phase.","completed","NaviCam Patency Capsule for Gastrointestinal Patency","This study is testing a device called the NaviCam Patency Capsule. This capsule helps doctors check if your digestive tract (gastrointestinal tract) is clear before you have another procedure called capsule endoscopy. You might be able to join if you are between 22 and \"None\" years old and have a known or suspected intestinal stricture (a narrowing of the intestine), Crohn's disease, or abdominal pain from long-term use of certain pain relievers (NSAIDs). The study aims to see how safe and effective the patency capsule is within 30 hours. The current recruitment status is unclear, and the study plans to enroll 25 participants.","The safety and efficacy of the patency capsule are measured at 30 hours.",103,"You would swallow a patency capsule and then have an abdominal X-ray scan within 30 hours to see if the capsule is still in your body.","Not stated in the trial record.",[34],"v2"]