[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04561791":3,"trial-entities:NCT04561791":87,"trial-summary:NCT04561791":90},{"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":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":41,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":68,"locations":71,"central_contacts":80,"overall_officials":81,"references":85,"see_also_links":86},"NCT04561791","2018P002403","Evaluation of Tethered Capsule Endomicroscopy as a Screening Tool for Barrett's Esophagus in the Primary Care Setting","ENROLLING_BY_INVITATION","2029-12-31","2025-10","2025-10-22","2019-01-02","Massachusetts General Hospital","OTHER",false,"The investigators will conduct a large study in the primary care clinic to determine the feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus (BE) in the primary care practice environment. The investigators are also determining the prevalence of Barrett's esophagus in a primary care practice cohort at MGH.","The investigators have developed a tethered capsule OCT device intended as an inexpensive screening tool for BE. The capsule, which is attached to a thin, flexible tether, is reusable after being processed by a standard disinfection technique. Used without sedation, the capsule is swallowed by the participant and travels in the esophagus to the gastroesophageal junction (GEJ) via peristalsis. Cross-sectional microscopic OCT images of the entire esophagus are collected during transit. The total time needed for swallowing, imaging and retrieval does not exceed 10 minutes, with a total of 30 minutes for the procedure. The investigators have tested the feasibility and the tolerability of this new OCT screening technology in 250 procedures in healthy volunteers and participants with various esophageal diseases including BE. The procedure has been safe and well tolerated. High quality microscopic images of the esophagus have been obtained in 90% of the enrolled participants.",[18,19,20],"Barrett Esophagus","Barrett's Esophagus Without Dysplasia","Barretts Esophagus With Dysplasia",[22,23,24,25,26,27],"OCT","Optical Coherence Tomography","Endomicroscopy","Capsule Endomicroscopy","Tethered Capsule Endomicroscopy","TCE","INTERVENTIONAL","SCREENING",[31],"NA",{"count":33,"type":34},650,"ESTIMATED",[36],{"type":37,"name":26,"description":38,"armGroupLabels":39},"DEVICE","Participants will be asked to swallow the TCE device. Participants may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE device is past the pharynx. The TCE device will be advanced until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.",[40],"Feasibility of TCE & Prevalence of BE",[42,46],{"measure":43,"description":44,"timeFrame":45},"Subject Tolerability of Tethered Capsule Endomicroscopy Swallow","The study team will ask the participant about their comfort level throughout the procedure. Participants will be asked to score the tolerability of the procedure using a scoring system from 0-10. 0= the least tolerable, 10= the most tolerable. The title of the scale is Subject Tolerability Questionnaire.","During the single study visit (avg 30.mins), and before leaving, the participant will fill out the tolerability survey",{"measure":47,"description":48,"timeFrame":49},"Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.","The PI will identify signs of Barrett's esophagus from the imaging data. This is a qualitative assessment performed by the PI, as this imaging technique is to novel to have standard quality grading.","Imaging data is collected during the procedure, and analyzed within 1 year of collection.",[],"ALL","18 Years","75 Years",true,{"inclusion":56,"exclusion":61,"raw_text":67},[57,58,59,60],"Participants registered as patients at the Assembly Row primary care practice, MGH Broadway Primary Care - Revere, or Pentucket Medical Associates","18 years or older","Able to give informed consent","Participants must have no food for 1 hour before the procedure",[62,63,64,65,66],"Participants older than 75 years.","Participants with current symptoms of dysphagia","Participants with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and\u002For stomach surgeries), or history of intestinal Crohn's disease","Pregnancy","Participants scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.","Inclusion Criteria:\n\n* Participants registered as patients at the Assembly Row primary care practice, MGH Broadway Primary Care - Revere, or Pentucket Medical Associates\n* 18 years or older\n* Able to give informed consent\n* Participants must have no food for 1 hour before the procedure\n\nExclusion Criteria:\n\n* Participants older than 75 years.\n* Participants with current symptoms of dysphagia\n* Participants with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and\u002For stomach surgeries), or history of intestinal Crohn's disease\n* Pregnancy\n* Participants scheduled for an urgent care visit for the following symptoms: fever, sore throat, upper respiratory infection symptoms, nausea, vomiting, diarrhea, abdominal pain, or other symptoms as per clinical staff discretion.",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":12,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"Boston","Massachusetts","02114","United States",{"lat":78,"lon":79},42.35843,-71.05977,[],[82],{"name":83,"affiliation":12,"role":84},"Guillermo Tearney, M.D, PhD.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":88,"biomarkers":89},[18],[],{"nct_id":4,"found":54,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an interventional study with a planned enrollment of 650 participants. It is not specified if it is randomized or blinded.","completed","Tethered Capsule Endomicroscopy for Barrett's Esophagus Screening","This study is evaluating a new screening tool called Tethered Capsule Endomicroscopy (TCE) for Barrett's Esophagus (a condition where the lining of the esophagus changes, sometimes leading to cancer). Researchers want to see if TCE can be used effectively in a primary care doctor's office. You would swallow the TCE device, which is a small capsule attached to a thin string, to take pictures of your esophagus. The main goals are to see how well people tolerate swallowing the device and to find out how common Barrett's Esophagus is among patients in these primary care practices. The study is looking for participants aged 18 to 75 who are patients at specific primary care practices.","Your tolerability will be assessed during the single study visit. Imaging data will be analyzed within one year of collection.",114,"You would have one study visit lasting about 30 minutes. During this visit, you would swallow the TCE device and complete a tolerability survey.","Not stated in the trial record.",[26],"v2"]