[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03123835":3,"trial-entities:NCT03123835":98,"trial-summary:NCT03123835":106},{"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":25,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":40,"interventions":43,"primary_outcomes":52,"secondary_outcomes":57,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":77,"locations":80,"central_contacts":90,"overall_officials":91,"references":96,"see_also_links":97},"NCT03123835","676956","Outcome Analysis of POEM and Endoluminal Therapies","Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms","ENROLLING_BY_INVITATION","2031-12","2025-12","2025-12-05","2016-03","University of California, Davis","OTHER",false,"Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.","Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.",[19,20,21,22,23,24],"Achalasia","Gastric Fistula","Weight Gain After Primary Weight Loss Surgery","Marginal Ulcer","Stenoses","Gastric Nec",[19,26,27,28,29,30,31,32,33,34,35],"Fistula","Obesity","POEM","GERD","endoscopic","treatments","post bariatric surger weight gain","endoluminal","Bariatric Surgery","Barretts","INTERVENTIONAL","TREATMENT",[39],"NA",{"count":41,"type":42},500,"ESTIMATED",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":50},"PROCEDURE","Endoscopic Intervention","After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic\u002Ftherapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.",[49],"Treatment",[51],"Endoluminal Therapies, POEM, Endoscopic Revision",[53],{"measure":54,"description":55,"timeFrame":56},"Decrease in GERDDQ","Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)","3-6 months",[58],{"measure":59,"description":60,"timeFrame":61},"Decrease in Eckardt scoring","Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)","30 days","ALL","18 Years","80 Years",true,{"inclusion":67,"exclusion":74,"raw_text":76},[68,69,70,19,71,72,73],"Adult male and female patients 18-80 years of age","Meet the criteria for surgery of benign and\u002For malignant gastrointestinal pathology(s)","Gastrointestinal Reflux Disease","Barrett's Esophagus","Post Bariatric Surgery conditions","Other gastrointestinal and postsurgical disorders.",[75],"Adults unable to consent","Inclusion Criteria:\n\n* Adult male and female patients 18-80 years of age\n* Meet the criteria for surgery of benign and\u002For malignant gastrointestinal pathology(s)\n* Gastrointestinal Reflux Disease\n* Achalasia\n* Barrett's Esophagus\n* Post Bariatric Surgery conditions\n* Other gastrointestinal and postsurgical disorders.\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Univesity of California Davis Health System","Sacramento","California","95817","United States",{"lat":88,"lon":89},38.58157,-121.4944,[],[92],{"name":93,"affiliation":94,"role":95},"Mohamed R Ali, MD","U.C. Davis Medical Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":105},[19,100,101,102,20,103,104],"Barrett Esophagus","Digestive System Disorder","Digestive System Stenosis","Gastric Necrotic Lesion","Post-Bariatric Surgery Complications",[],{"nct_id":4,"found":15,"summary":107,"prompt_version":107},null]