[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06571669":3,"trial-entities:NCT06571669":341,"trial-summary:NCT06571669":344},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":15,"eligibility_criteria":44,"std_ages":68,"locations":71,"central_contacts":329,"overall_officials":338,"references":339,"see_also_links":340},"NCT06571669","BOOM-IBD2 (CIP-B02)","BOOM-IBD2 Pivotal Clinical Trial","BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.","RECRUITING","2027-11-30","2026-08","2026-08-06","2025-01-31","Boomerang Medical","INDUSTRY",false,"Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.","The main goal is to find out if bowel urgency gets better after 12 weeks, using a standard rating scale for bowel urgency. Adults ages 18 to 85 with ulcerative colitis may be able to join. Everyone in the study gets the device. There is no placebo group. Study visits continue for 12 months.",[19,20],"Ulcerative Colitis","Inflammatory Bowel Diseases",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},137,"ESTIMATED",[30],{"type":31,"name":32,"description":32,"armGroupLabels":33},"DEVICE","Neuromodulation",[34],"Treatment Arm",[36],{"measure":37,"description":38,"timeFrame":39},"Bowel Urgency","Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.","12 weeks",[],"ALL","18 Years","85 Years",{"inclusion":45,"exclusion":51,"raw_text":67},[46,47,48,49,50],"Male or female","18 to 85 years of age","Diagnosed with ulcerative colitis","Ability and willingness to consent to participate by signing the informed consent form","Ability to comply with the protocol and willingness to comply with all follow up requirements",[52,53,54,55,56,57,58,59,60,61,62,63,64,65,66],"Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study","Any psychiatric or personality disorder at the discretion of the study investigator","Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)","Active clostridium difficile infection of the colon","Active cytomegalovirus (CMV) infection of the colon","Evidence of colonic perforation","Fulminant colitis requiring emergency surgery","Microscopic, ischemic or infectious colitis","Unresected neoplasia of the colon","Colonic stricture unable to pass a colonoscope","Current evidence of cancer in the gastrointestinal tract","Current participation in another clinical trial","Previous history of surgery for ulcerative colitis, or probably to require such intervention","Previously implanted with a neurostimulation device or participated in a neurostimulation trial","Inability to operate the patient programmer","Inclusion Criteria:\n\n* Male or female\n* 18 to 85 years of age\n* Diagnosed with ulcerative colitis\n* Ability and willingness to consent to participate by signing the informed consent form\n* Ability to comply with the protocol and willingness to comply with all follow up requirements\n\nExclusion Criteria:\n\n* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study\n* Any psychiatric or personality disorder at the discretion of the study investigator\n* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)\n* Active clostridium difficile infection of the colon\n* Active cytomegalovirus (CMV) infection of the colon\n* Evidence of colonic perforation\n* Fulminant colitis requiring emergency surgery\n* Microscopic, ischemic or infectious colitis\n* Unresected neoplasia of the colon\n* Colonic stricture unable to pass a colonoscope\n* Current evidence of cancer in the gastrointestinal tract\n* Current participation in another clinical trial\n* Previous history of surgery for ulcerative colitis, or probably to require such intervention\n* Previously implanted with a neurostimulation device or participated in a neurostimulation trial\n* Inability to operate the patient programmer",[69,70],"ADULT","OLDER_ADULT",[72,90,103,117,130,144,159,173,187,202,216,228,242,251,266,280,294,308,321],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"Gastroenterology Medical Clinic (Objective Health)","Folsom","California","95630","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Clinical Trial Coordinator","CONTACT","916-226-6044","grecia.perez@objective.health",{"name":85,"role":86},"Nazir Rahim, MD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},38.67796,-121.17606,{"facility":91,"status":8,"city":92,"state":75,"zip":93,"country":77,"contacts":94,"geoPoint":100},"Center for Colorectal Innovation","Los Angeles","90048",[95,98],{"name":80,"role":81,"phone":96,"email":97},"(310) 289-9224","Gayane.Ovsepyan@cshs.org",{"name":99,"role":86},"Karen Zaghiyan",{"lat":101,"lon":102},34.05223,-118.24368,{"facility":104,"status":8,"city":105,"state":75,"zip":106,"country":77,"contacts":107,"geoPoint":114},"Hoag Hospital","Newport Beach","92663",[108,112],{"name":80,"role":81,"phone":109,"phoneExt":110,"email":111},"949-764-5597","45597","Vianh.Truong@hoag.org",{"name":113,"role":86},"Caroline Hwang",{"lat":115,"lon":116},33.61891,-117.92895,{"facility":118,"status":8,"city":119,"state":75,"zip":120,"country":77,"contacts":121,"geoPoint":127},"PAMF (Palo Alto Medical Foundation)","Palo Alto","94301",[122,125],{"name":80,"role":81,"phone":123,"email":124},"510-204-1609","myesha.kirk@sutterhealth.org",{"name":126,"role":86},"Ryan McConnell",{"lat":128,"lon":129},37.44188,-122.14302,{"facility":131,"status":8,"city":132,"state":133,"zip":134,"country":77,"contacts":135,"geoPoint":141},"Kansas Gastro","Wichita","Kansas","67226-8119",[136,139],{"name":80,"role":81,"phone":137,"email":138},"(316) 730-1029","jessica_wewer@ksgastro.com",{"name":140,"role":86},"Michael Lievens, MD",{"lat":142,"lon":143},37.69224,-97.33754,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":77,"contacts":149,"geoPoint":156},"MN Urology","Woodbury","Minnesota","55125",[150,154],{"name":151,"role":81,"phone":152,"email":153},"Clinical Research Manager","651-999-6903","cmckenzie@mnurology.com",{"name":155,"role":86},"Jodi Michaels, MD",{"lat":157,"lon":158},44.92386,-92.95938,{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":77,"contacts":164,"geoPoint":170},"GI Alliance","Jackson","Mississippi","39232",[165,168],{"name":80,"role":81,"phone":166,"email":167},"601-863-0395","jesus.monico@gastrodocs.net",{"name":169,"role":86},"Reed Hogan, MD",{"lat":171,"lon":172},32.29876,-90.18481,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":77,"contacts":178,"geoPoint":184},"Gateway GI Research (Objective Health)","St Louis","Missouri","63141",[179,182],{"name":80,"role":81,"phone":180,"email":181},"636-214-5291","kristen.strubberg@objective.health",{"name":183,"role":86},"Brian McMorrow, MD",{"lat":185,"lon":186},38.62727,-90.19789,{"facility":188,"status":8,"city":189,"state":190,"zip":191,"country":77,"contacts":192,"geoPoint":199},"Las Vegas Medical Research LLC, DBA Vector Clinical Trials","Las Vegas","Nevada","89128",[193,197],{"name":80,"role":81,"phone":194,"phoneExt":195,"email":196},"+1 702-750-0000","104","betsyj@vectorclinicaltrials.com",{"name":198,"role":86},"Christian Stone",{"lat":200,"lon":201},36.17497,-115.13722,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":77,"contacts":207,"geoPoint":213},"Northwell Health North Shore University Hospital","Manhasset","New York","11030",[208,211],{"name":80,"role":81,"phone":209,"email":210},"516-504-3955","mmanoharan@northwell.edu",{"name":212,"role":86},"Keith Sultan, MD",{"lat":214,"lon":215},40.79788,-73.69957,{"facility":217,"status":8,"city":205,"state":205,"zip":218,"country":77,"contacts":219,"geoPoint":225},"Columbia University Irving Medical Center\u002FNew York Presbyterian Hospital","10032",[220,223],{"name":80,"role":81,"phone":221,"email":222},"212-342-4102","eb3709@cumc.columbia.edu",{"name":224,"role":86},"Marco Zoccali, MD",{"lat":226,"lon":227},40.71427,-74.00597,{"facility":229,"status":8,"city":230,"state":231,"zip":232,"country":77,"contacts":233,"geoPoint":239},"UNC Chapel Hill","Chapel Hill","North Carolina","27599",[234,237],{"name":80,"role":81,"phone":235,"email":236},"919-843-8105","emily_english@med.unc.edu",{"name":238,"role":86},"Millie Long, MD",{"lat":240,"lon":241},35.9132,-79.05584,{"facility":243,"status":244,"city":245,"state":246,"zip":247,"country":77,"geoPoint":248},"Great Lakes Gastro","WITHDRAWN","Mentor","Ohio","44060",{"lat":249,"lon":250},41.66616,-81.33955,{"facility":252,"status":253,"city":254,"state":255,"zip":256,"country":77,"contacts":257,"geoPoint":263},"Pennsylvania Hospital","NOT_YET_RECRUITING","Philadelphia","Pennsylvania","19107",[258,261],{"name":80,"role":81,"phone":259,"email":260},"215-439-1902","alice.chen1@pennmedicine.upenn.edu",{"name":262,"role":86},"Joshua Bleier, MD",{"lat":264,"lon":265},39.95238,-75.16362,{"facility":267,"status":8,"city":268,"state":269,"zip":270,"country":77,"contacts":271,"geoPoint":277},"Columbia Digestive Health Research (Objective Health)","Columbia","South Carolina","29204",[272,275],{"name":80,"role":81,"phone":273,"email":274},"803-386-8933","marissa.white@objective.health",{"name":276,"role":86},"Edward Kimbrough, MD",{"lat":278,"lon":279},34.00071,-81.03481,{"facility":281,"status":8,"city":282,"state":283,"zip":284,"country":77,"contacts":285,"geoPoint":291},"Sanford Health","Sioux Falls","South Dakota","57105",[286,289],{"name":80,"role":81,"phone":287,"email":288},"605-328-1379","ashley.puetz@sanfordhealth.org",{"name":290,"role":86},"Kevin Benson, MD",{"lat":292,"lon":293},43.54369,-96.72796,{"facility":295,"status":8,"city":296,"state":297,"zip":298,"country":77,"contacts":299,"geoPoint":305},"Amarillo Premier Research (Objective Health)","Amarillo","Texas","79106",[300,303],{"name":80,"role":81,"phone":301,"email":302},"806-641-0256","lauren.kuehler@objective.health",{"name":304,"role":86},"Susan Neese",{"lat":306,"lon":307},35.222,-101.8313,{"facility":309,"status":8,"city":310,"state":297,"zip":311,"country":77,"contacts":312,"geoPoint":318},"Digestive Research of Central Texas (Objective Health)","Waco","76712",[313,316],{"role":81,"phone":314,"email":315},"(254) 523-4187","Victoria.Rico@objective.health",{"name":317,"role":86},"Hanumantha Ancha",{"lat":319,"lon":320},31.54933,-97.14667,{"facility":322,"status":323,"city":324,"state":297,"zip":325,"country":77,"geoPoint":326},"Digestive Health Research of North Texas (Objective Health)","ACTIVE_NOT_RECRUITING","Wichita Falls","76301",{"lat":327,"lon":328},33.91371,-98.49339,[330,334],{"name":331,"role":81,"phone":332,"email":333},"Deborah Reasner","210-722-6192","deb@boomerangmedical.com",{"name":335,"role":81,"phone":336,"email":337},"Bruce Van Deman","949-413-1301","bruce@boomerangmedical.com",[],[],[],{"nct_id":4,"conditions":342,"biomarkers":343},[19],[],{"nct_id":4,"found":345,"summary":346,"prompt_version":356},true,{"design":347,"status":348,"heading":349,"summary":350,"follow_up":351,"word_count":352,"commitments":353,"compensation":354,"drugs_mentioned":355},"This is an interventional study with a planned enrollment of 137 participants. Everyone in the study will receive the neuromodulation device.","completed","BOOM-IBD2 Study for Ulcerative Colitis","This study, called BOOM-IBD2, is testing a neuromodulation device for people with ulcerative colitis (a long-lasting condition causing swelling and sores in the large intestine). The device is small and placed under your skin during a same-day procedure. It sends mild signals to a nerve near your tailbone. The main goal is to see if this device can help reduce bowel urgency after 12 weeks. Adults aged 18 to 85 who have been diagnosed with ulcerative colitis and are willing to follow study requirements may be able to join. The current recruitment status is unclear.","The primary endpoint for measuring bowel urgency is at 12 weeks. Study visits continue for 12 months.",95,"You would have the neuromodulation device placed during a same-day procedure. Study visits will continue for 12 months.","Not stated in the trial record.",[32],"v2"]