[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03876288":3,"trial-entities:NCT03876288":95,"trial-summary:NCT03876288":98},{"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":23,"interventions":26,"primary_outcomes":48,"secondary_outcomes":53,"sex":54,"minimum_age":21,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":59,"locations":63,"central_contacts":76,"overall_officials":80,"references":83,"see_also_links":94},"NCT03876288","20.0697","Gastroparesis Outcome Longitudinal Database Enrolled Numerically","RECRUITING","2028-01-01","2025-07","2026-04-20","2013-01-01","University of Louisville","OTHER",false,"GOLDEN is a longitudinal database of patients with the symptoms (Sx) of gastroparesis (Gp) who were seen and recorded at the University of Louisville from 2012 and is ongoing. Patients are enrolled and followed by sequential numbers and may include legacy patients seen at other centers by some of the same team and who are reported as part of the series. Outcome relate to patients Sx, survival, quality of life and other measures as detailed below, over time. The study tracks patients regardless of treatment but specifically focuses on GI Neuromodulation (gastric electrical stimulation - GES), Immunotherapy (IVIG), and Pyloric therapies (pyloroplasty, endoscopic). If treatments were administered GOLDEN allows for examination and stratification of outcome by groups both at baseline and at follow up.","1. All patients seen with the Sx of Gp and who were evaluated for diagnosis and\u002For treatment\n2. Including legacy patients who were seen and treated at previous locations (Mississippi, Arkansas, Tennessee) before Kentucky if they were part of a clinical research series.\n3. Numbers of patients referred or consulted for Gp Sx who were Drug Refractory.\n4. Interventions: GI Neuromodulation with gastric electrical stimulation (GES); Immunotherapy with Intravenous Immunoglobulin; Pyloric therapies such as pyloroplasty, surgical or endoscopic.\n5. Data for evaluation by: Sx assessments by whatever scales used; Measures of health related quality of life; Psychological and pain assessments; Gastric emptying texts; Electrical measures including the following: single channel, low resolution and high resolution EGG, plus mucosal and serosal electrograms. High resolution EGG is also called Body Surface Mapping which is frequently measured in our patient population. ; Autonomic measure; Serologic measures; Full thickness biopsies; Measures of outpatient \\& Emergency Room Visits; Measures of hospitalization; Placement of endoscopic or surgical tubes; Radiological and Surgical procedures; Nutritional assessments; If enrolled in any research protocols for data; Stool biome measures; Metabolic measures; Other morbidity measures; Mortality\n6. One of the areas that GOLDEN looks at is High Resolution EGG or Body Surface Mapping (BSM). This specific area included normal control data along with collaborations with the U of Auckland the Temple University. The goals of the BSM portion of GOLDEN are as follows:\n\n   * Goal1: Define Normal Body Surface Gastric Mapping (BSGM) Ranges and Activity Profiles in Adults\n   * Goal 2. Define Spatial Patterns of Abnormal Gastric Electrophysiology in a Large Patient Cohort\n   * Goal 3: Define Mechanistic Consequences of Retrograde Gastric Slow Wave Activation on Gastric Emptying, Gastric Contractions, and Reflux Events\n\nWork to meet these goals are ongoing",[18],"Gastroparesis",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},3000,"ESTIMATED",[27,35,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"DEVICE","GI Neuromodulation","The investigators would include follow up with: No treatment; temp GES only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological\u002Fbehavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.",[32],"People presenting with the Sx of Gp",[34],"Gastric electrical stimulation (GES)",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Immunotherapy","The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological\u002Fbehavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.",[32],[41],"Intravenous immunoglobulin",{"type":43,"name":44,"description":38,"armGroupLabels":45,"otherNames":46},"PROCEDURE","Pyloric Therapies",[32],[47],"Pyloromyotomy",[49],{"measure":50,"description":51,"timeFrame":52},"Patient Reported Outcome GI Symptoms","The primary outcome measures are patient symptoms via the traditional gastroparesis patient reported outcome scale. It uses a 0-4 scale from none to worse on GI Symptoms; for example: Nausea,Vomiting, Anorexia\u002FEarly Satiety, Bloating\u002Fdistension, Abdominal Pain. Scored as each item plus a total that is the sum of the individual scales.The five Sx subscales of 0-4 each are summed for a total score range 0-20","Change from baseline to one week to one year",[],"ALL",{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion:\n\n* Patients with the symptoms (Sx) of drug refractory gastroparesis\n* Disordered nutrition by standardized assessment\n* Ability to assess current symptom status\n* Ability to measure other medical conditions\n\nExclusion:\n\n* Anatomic obstruction of the GI Tract\n* Pregnancy\n* Inability of patient or guardian to sign informed consent, if needed\n* Psychiatric disorders precluding assessment and treatment of the patient's GI condition",[60,61,62],"CHILD","ADULT","OLDER_ADULT",[64],{"facility":12,"status":7,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":73},"Louisville","Kentucky","40202","United States",[70],{"name":71,"role":72},"Thomas Abell, MD","CONTACT",{"lat":74,"lon":75},38.25424,-85.75941,[77],{"name":71,"role":72,"phone":78,"email":79},"(502)852-6991","thomas.abell@louisville.edu",[81],{"name":71,"affiliation":12,"role":82},"PRINCIPAL_INVESTIGATOR",[84,88,91],{"pmid":85,"type":86,"citation":87},"41307525","DERIVED","Kasem F, Naing LY, Mathur P, McElmurray L, Moppins C, Daniels MW, Stocker A, Abell TL, Omer E. Patients With Gastroparesis Symptoms After Gastric Electrical Stimulation With and Without Tube Feedings. Neuromodulation. 2025 Nov 26:S1094-7159(25)00687-7. doi: 10.1016\u002Fj.neurom.2025.07.008. Online ahead of print.",{"pmid":89,"type":86,"citation":90},"36626193","Kochar T, Cai W, Guardiola JJ, Mathur P, Hassan H, Atassi H, Stocker A, Hughes M, McElmurray L, Pinkston C, Abell TL. Nutritional Assessment in Patients after Gastric Electrical Stimulation (GES). J Clin Gastroenterol. 2024 Feb 1;58(2):136-142. doi: 10.1097\u002FMCG.0000000000001826.",{"pmid":92,"type":86,"citation":93},"35183451","Shine A, Mathur P, Ahmed S, Ramos S, McElmurray L, Stocker A, Pinkston C, Abell TL. Low-Resolution Electrogastrogram at Baseline and Response to Temporary Gastric Electrical Stimulation-A Comparison of Cutaneous With Mucosal Recordings. Neuromodulation. 2022 Dec;25(8):1150-1159. doi: 10.1016\u002Fj.neurom.2021.12.008. Epub 2022 Feb 17.",[],{"nct_id":4,"conditions":96,"biomarkers":97},[18],[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study, meaning researchers will collect information about your health and treatments over time. It is not a clinical trial where you receive a new treatment.","completed","Observational Study of Gastroparesis Treatments","This is an observational study called GOLDEN that collects information from people with gastroparesis (a condition where your stomach empties too slowly). Researchers are looking at how different treatments affect symptoms, survival, and quality of life over time. These treatments include GI Neuromodulation (like gastric electrical stimulation, or GES), Immunotherapy (like Intravenous Immunoglobulin), and Pyloric therapies (like pyloroplasty). You might be able to join if you have gastroparesis symptoms that haven't improved with other medicines, have nutrition problems, and can describe your current symptoms. You cannot join if you have a blockage in your digestive system, are pregnant, or have certain psychiatric disorders. The study is ongoing and aims to include 3000 participants.","Your symptoms will be followed from when you start the study up to one year.",113,"Not specified in the trial record.","Not stated in the trial record.",[29,37,44],"v2"]