[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04565704":3,"trial-entities:NCT04565704":73,"trial-summary:NCT04565704":77},{"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":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":54,"locations":57,"central_contacts":66,"overall_officials":67,"references":71,"see_also_links":72},"NCT04565704","2015P000328","Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology","ENROLLING_BY_INVITATION","2028-12-31","2025-10","2025-10-22","2016-03-25","Massachusetts General Hospital","OTHER",false,"To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.","The investigators have previously developed optical imaging systems that have been able to provide highly detailed images of tissue structures in multiple application areas including Cardiology, Gastroenterology, and Pulmonology. They are looking to continue the advancement of these various technologies under development.\n\nThe population will include participants who are undergoing elective esophagogastroduodenoscopy with biopsy, colonoscopy with biopsy, and\u002For endo-mucosal resection.The endoscopist will take no more than 3 biopsies in addition to the standard of care biopsies.\n\nThe study will be optical imaging of the ex vivo GI specimens that are being collected. Specimens will be collected for research purposes only. Offline analysis of the samples will be performed, and optical imaging findings will be correlated with the pathology findings. This will require review of the medical record to link the findings of the imaging with the pertinent medical information. Samples will be de-identified and participants will be assigned a unique number. The tissues will be placed in marked containers labeled \"for research purposes only\". The samples collected will be brought to the Tearney Research Laboratory for imaging and processing. The Optical imaging of the tissue samples will not affect the standard of care procedure.",[18,19],"Gastrointestinal Disease","Gastrointestinal Dysfunction",[21,22,23,24,25,26],"OCT","Optical Coherence Tomography","Biopsy","GI disease","Endoscopy screening","Endoscopic Screening","INTERVENTIONAL","DEVICE_FEASIBILITY",[30],"NA",{"count":32,"type":33},200,"ESTIMATED",[35],{"type":36,"name":37,"armGroupLabels":38},"DEVICE","Biopsy imaged by Optical imaging device.",[39],"Development of novel optical imaging technologies",[41],{"measure":42,"description":43,"timeFrame":44},"Device Feasibility based on image quality and presence of microscopic features","The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirming that microscopic features observed in the images are also seen by correlative histopathology, 3) ability to develop preliminary criteria or algorithms based on image-histopathology matches.","Imaging data is collected during the procedure, and analyzed within 1 year of collection.",[],"ALL","18 Years",null,true,{"inclusion":51,"exclusion":52,"raw_text":53},[],[],"Inclusion Criteria:\n\n• Scheduled for an elective esophagoduodenoscopy and\u002For colonoscopy\n\nExclusion Criteria:\n\n• According to standard of care at MGH endoscopy department.",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":12,"city":59,"state":60,"zip":61,"country":62,"geoPoint":63},"Boston","Massachusetts","02114","United States",{"lat":64,"lon":65},42.35843,-71.05977,[],[68],{"name":69,"affiliation":12,"role":70},"Guillermo Tearney, M.D, PhD.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":74,"biomarkers":76},[75,19],"Digestive System Disorder",[],{"nct_id":4,"found":49,"summary":78,"prompt_version":88},{"design":79,"status":80,"heading":81,"summary":82,"follow_up":83,"word_count":84,"commitments":85,"compensation":86,"drugs_mentioned":87},"This is an interventional study with a planned enrollment of 200 participants. It is not specified if it is randomized or blinded.","completed","Optical Imaging for Gastrointestinal Biopsy Analysis","This study is exploring a new way to look at biopsy samples (small tissue samples) from your gastrointestinal (GI) tract using an optical imaging device. The goal is to see if this device can help doctors better detect and diagnose GI diseases without destroying the biopsy tissue. You might be able to join if you are at least 18 years old and are already scheduled for an esophagoduodenoscopy (a procedure to look at your esophagus, stomach, and the first part of your small intestine) or a colonoscopy (a procedure to look at your large intestine) at Massachusetts General Hospital. The study will be considered successful if the images from the device are of good quality and show microscopic features that can be compared to standard pathology results. The current status of this study is unclear.","Imaging data will be analyzed within one year of collection, but no specific follow-up for participants is mentioned.",135,"If you participate, up to three extra biopsy samples will be taken during your scheduled endoscopy procedure. These samples will then be imaged and analyzed for research purposes.","Not stated in the trial record.",[],"v2"]