[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376161":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":43,"locations":52,"responsibleParty":397,"collaborators":400,"id":439,"slug":440,"hasResults":441,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":441,"sex":447,"minAge":448,"maxAge":449,"enrollmentInfo":450,"targetDuration":25,"studyType":453,"phases":454,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":55,"whyStopped":25,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":472},{"fullName":5,"class":6},"University of Utah","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ETV+CPC","ACTIVE_COMPARATOR","Subjects randomized to this arm will undergo an ETV+CPC procedure for treatment of Hydrocephalus",[13],"Procedure: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)",{"label":15,"type":10,"description":16,"interventionNames":17},"Ventriculoperitoneal Shunt","Subjects randomized to this arm will undergo a Ventriculoperitoneal Shunt procedure for treatment of Hydrocephalus",[18],"Device: Ventriculoperitoneal Shunt",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC)","Since the early 1990s, ETV has become the main alternative to shunting for hydrocephalus. This procedure involves placing an endoscopic camera into the ventricles of the brain and creating a hole in the floor of the third ventricle to act as an internal bypass for obstructed CSF. The cauterization of choroid plexus (CPC) involves the use of a device to burn or cauterize tissue from the choroid plexus. The choroid plexus of the brain exists in the lateral ventricles, the third ventricle, and the fourth ventricle. Its main role is the production of CSF. The success of ETV alone is poor in infants, but when combined with CPC, improved results have been observed and ETV+CPC has become a safe viable option for these children.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"DEVICE","The most common treatment for hydrocephalus has been the insertion of a ventriculoperitoneal shunt, which has been in popular use for over 50 years. This consists of silastic tubing attached to a valve mechanism that runs subcutaneously from the head to the abdomen. It is one of the most common procedures performed by pediatric neurosurgeons.",[15],[31,34,38,41],{"name":32,"affiliation":5,"role":33},"John Kestle, MD","STUDY_CHAIR",{"name":35,"affiliation":36,"role":37},"Abhaya Kulkarni, MD","University of Toronto","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"David Limbrick, MD","Washington University School of Medicine",{"name":42,"affiliation":5,"role":37},"Richard Holubkov, PhD",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":25,"email":48},"Nichol Nunn","CONTACT","801-458-6593","nichol.nunn@hsc.utah.edu",{"name":50,"role":46,"phone":25,"phoneExt":25,"email":51},"Jason Clawson","jason.clawson@hsc.utah.edu",[53,74,91,107,124,135,152,167,183,199,219,235,252,261,283,300,316,326,344,363,379],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Children's of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-86.80249,33.52066,{"lat":65,"lon":64},[68,72],{"name":69,"role":46,"phone":70,"phoneExt":25,"email":71},"Anastasia Smith, MPH","205-638-5018","Anastasia.Smith@childrensal.org",{"name":73,"role":37,"phone":25,"phoneExt":25,"email":25},"Curtis Rozzelle, MD",{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":59,"countryCode":60,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Phoenix Children's Hospital","NOT_YET_RECRUITING","Phoenix","Arizona","85016",{"type":62,"coordinates":81},[82,83],-112.07404,33.44838,{"lat":83,"lon":82},[86,89],{"name":87,"role":46,"phone":25,"phoneExt":25,"email":88},"Bethany Norton","bnorton1@phoenixchildrens.com",{"name":90,"role":37,"phone":25,"phoneExt":25,"email":25},"Jason Hauptman",{"facility":92,"status":55,"city":93,"state":94,"zip":95,"country":59,"countryCode":60,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Children's Hospital of Los Angeles","Los Angeles","California","90027",{"type":62,"coordinates":97},[98,99],-118.24368,34.05223,{"lat":99,"lon":98},[102,105],{"name":103,"role":46,"phone":25,"phoneExt":25,"email":104},"Helen Berroya","hberroya@chla.usc.edu",{"name":106,"role":37,"phone":25,"phoneExt":25,"email":25},"Mark Krieger, MD",{"facility":108,"status":55,"city":109,"state":110,"zip":111,"country":59,"countryCode":60,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Children's Hospital Colorado","Aurora","Colorado","80045",{"type":62,"coordinates":113},[114,115],-104.83192,39.72943,{"lat":115,"lon":114},[118,122],{"name":119,"role":46,"phone":120,"phoneExt":25,"email":121},"Susan Staulcup, 80045","303-724-5935","SUSAN.STAULCUP@UCDENVER.EDU",{"name":123,"role":37,"phone":25,"phoneExt":25,"email":25},"Todd Hankinson, MD",{"facility":125,"status":126,"city":127,"state":128,"zip":129,"country":59,"countryCode":60,"cosmosGeoPoint":130,"geoPoint":134,"contacts":25},"Yale University","ACTIVE_NOT_RECRUITING","New Haven","Connecticut","06520",{"type":62,"coordinates":131},[132,133],-72.92816,41.30815,{"lat":133,"lon":132},{"facility":136,"status":55,"city":137,"state":138,"zip":139,"country":59,"countryCode":60,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Wolfson Children's Hospital","Jacksonville","Florida","32207",{"type":62,"coordinates":141},[142,143],-81.65565,30.33218,{"lat":143,"lon":142},[146,150],{"name":147,"role":46,"phone":148,"phoneExt":25,"email":149},"Asmaa Hatem","904-633-0993","Asmaa.Hatem@jax.ufl.edu",{"name":151,"role":37,"phone":25,"phoneExt":25,"email":25},"Philipp R. Aldana, MD",{"facility":153,"status":55,"city":154,"state":138,"zip":155,"country":59,"countryCode":60,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Arnold Palmer Hospital for Children","Orlando","32806",{"type":62,"coordinates":157},[158,159],-81.37924,28.53834,{"lat":159,"lon":158},[162,165],{"name":163,"role":46,"phone":25,"phoneExt":25,"email":164},"Richard Guerrero","richard.guerrero@orlandohealth.com",{"name":166,"role":37,"phone":25,"phoneExt":25,"email":25},"Samer Elbabaa, MD",{"facility":168,"status":76,"city":169,"state":170,"zip":171,"country":59,"countryCode":60,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Trustees of Indiana University","Indianapolis","Indiana","46202",{"type":62,"coordinates":173},[174,175],-86.15804,39.76838,{"lat":175,"lon":174},[178,181],{"name":179,"role":46,"phone":25,"phoneExt":25,"email":180},"Mariah Shirrell","mkillin@iu.edu",{"name":182,"role":37,"phone":25,"phoneExt":25,"email":25},"Jason Chu",{"facility":184,"status":55,"city":185,"state":186,"zip":187,"country":59,"countryCode":60,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Johns Hopkins Children's Center","Baltimore","Maryland","21287",{"type":62,"coordinates":189},[190,191],-76.61219,39.29038,{"lat":191,"lon":190},[194,197],{"name":195,"role":46,"phone":25,"phoneExt":25,"email":196},"Sydney White","swhit128@jh.edu",{"name":198,"role":37,"phone":25,"phoneExt":25,"email":25},"Eric Jackson, MD",{"facility":200,"status":55,"city":201,"state":202,"zip":203,"country":59,"countryCode":60,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"St. Louis Children's Hospital","St Louis","Missouri","63110",{"type":62,"coordinates":205},[206,207],-90.19789,38.62727,{"lat":207,"lon":206},[210,214,217],{"name":211,"role":46,"phone":212,"phoneExt":25,"email":213},"Diego Morales, MS","314-454-4688","moralesd@wudosis.wustl.edu",{"name":215,"role":46,"phone":25,"phoneExt":25,"email":216},"Mary Goldschmidt","goldschmidt@wustl.edu",{"name":218,"role":37,"phone":25,"phoneExt":25,"email":25},"Jennifer Strahle, MD, PhD",{"facility":220,"status":55,"city":221,"state":222,"zip":223,"country":59,"countryCode":60,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":62,"coordinates":225},[226,227],-82.99879,39.96118,{"lat":227,"lon":226},[230,233],{"name":231,"role":46,"phone":25,"phoneExt":25,"email":232},"Jared Haught","Jared.Haught@nationwidechildrens.org",{"name":234,"role":37,"phone":25,"phoneExt":25,"email":25},"Jonathan Pindrik, MD",{"facility":236,"status":55,"city":237,"state":238,"zip":239,"country":59,"countryCode":60,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15224",{"type":62,"coordinates":241},[242,243],-79.99589,40.44062,{"lat":243,"lon":242},[246,250],{"name":247,"role":46,"phone":248,"phoneExt":25,"email":249},"Kimberly Diamond, BS, BA","412-692-9965","diamondkl@upmc.edu",{"name":251,"role":37,"phone":25,"phoneExt":25,"email":25},"Ian Pollack, MD",{"facility":253,"status":126,"city":254,"state":238,"zip":255,"country":59,"countryCode":60,"cosmosGeoPoint":256,"geoPoint":260,"contacts":25},"The Pennsylvania State University","University Park","16802",{"type":62,"coordinates":257},[258,259],-77.85639,40.80201,{"lat":259,"lon":258},{"facility":262,"status":55,"city":263,"state":264,"zip":265,"country":59,"countryCode":60,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Monroe Carell Jr. Children's Hospital at Vanderbilt","Nashville","Tennessee","37232",{"type":62,"coordinates":267},[268,269],-86.78444,36.16589,{"lat":269,"lon":268},[272,275,279,281],{"name":273,"role":46,"phone":25,"phoneExt":25,"email":274},"Julia Loes","julia.loes@vumc.org",{"name":276,"role":46,"phone":277,"phoneExt":25,"email":278},"Stephen Gannon","615-936-6809","stephen.r.gannon@vumc.org",{"name":280,"role":37,"phone":25,"phoneExt":25,"email":25},"John C. Wellons, III, MD, MSPH",{"name":282,"role":37,"phone":25,"phoneExt":25,"email":25},"Robert Naftel, MD",{"facility":284,"status":55,"city":285,"state":286,"zip":287,"country":59,"countryCode":60,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Texas Children's Hospital","Houston","Texas","77030",{"type":62,"coordinates":289},[290,291],-95.36327,29.76328,{"lat":291,"lon":290},[294,298],{"name":295,"role":46,"phone":296,"phoneExt":25,"email":297},"Edgardo Santisbon","832-826-5208","exsantis@texaschildrens.org",{"name":299,"role":37,"phone":25,"phoneExt":25,"email":25},"William E. Whitehead, MD, MPH",{"facility":301,"status":55,"city":302,"state":303,"zip":304,"country":59,"countryCode":60,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Primary Children's Hospital","Salt Lake City","Utah","84118",{"type":62,"coordinates":306},[307,308],-111.89105,40.76078,{"lat":308,"lon":307},[311,315],{"name":312,"role":46,"phone":313,"phoneExt":25,"email":314},"Alli Ludwick","801-662-5352","allison.ludwick@hsc.utah.edu",{"name":32,"role":37,"phone":25,"phoneExt":25,"email":25},{"facility":317,"status":126,"city":318,"state":319,"zip":320,"country":59,"countryCode":60,"cosmosGeoPoint":321,"geoPoint":325,"contacts":25},"Virginia Commonwealth University","Richmond","Virginia","23284",{"type":62,"coordinates":322},[323,324],-77.46026,37.55376,{"lat":324,"lon":323},{"facility":327,"status":55,"city":328,"state":329,"zip":330,"country":59,"countryCode":60,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":62,"coordinates":332},[333,334],-122.33207,47.60621,{"lat":334,"lon":333},[337,340,342],{"name":338,"role":46,"phone":25,"phoneExt":25,"email":339},"Jessica Becerra","Jessica.Becerra@seattlechildrens.org",{"name":341,"role":37,"phone":25,"phoneExt":25,"email":25},"Hannah Goldstein, MD",{"name":343,"role":37,"phone":25,"phoneExt":25,"email":25},"Samuel Browd, MD, PhD",{"facility":345,"status":55,"city":346,"state":347,"zip":348,"country":349,"countryCode":350,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"Alberta Children's Hospital","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":62,"coordinates":352},[353,354],-114.08529,51.05011,{"lat":354,"lon":353},[357,361],{"name":358,"role":46,"phone":359,"phoneExt":25,"email":360},"Ruksana Rashid, MBBS MPH MSc","403-955-5738","rsrashid@ucalgary.ca",{"name":362,"role":37,"phone":25,"phoneExt":25,"email":25},"Jay Riva-Cambrin, MD",{"facility":364,"status":55,"city":365,"state":366,"zip":367,"country":349,"countryCode":350,"cosmosGeoPoint":368,"geoPoint":372,"contacts":373},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4",{"type":62,"coordinates":369},[370,371],-123.11934,49.24966,{"lat":371,"lon":370},[374,377],{"name":375,"role":46,"phone":25,"phoneExt":25,"email":376},"Annika Weirs","annika.weir@cw.bc.ca",{"name":378,"role":37,"phone":25,"phoneExt":25,"email":25},"Mandeep Tamber, MD, PhD",{"facility":380,"status":55,"city":381,"state":382,"zip":383,"country":349,"countryCode":350,"cosmosGeoPoint":384,"geoPoint":388,"contacts":389},"The Hospital for Sick Children","Toronto","Ontario","M5G 1X8",{"type":62,"coordinates":385},[386,387],-79.39864,43.70643,{"lat":387,"lon":386},[390,395],{"name":391,"role":46,"phone":392,"phoneExt":393,"email":394},"Homa Ashrafpour","416-813-7654","328771","homa.ashrafpour@sickkids.ca",{"name":396,"role":37,"phone":25,"phoneExt":25,"email":25},"Abhaya Kulkarni, MD, PhD",{"type":37,"investigatorFullName":398,"investigatorTitle":399,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"John Kestle","MD, Vice Chair of Clinical Research",[401,403,405,407,408,409,411,412,413,415,417,419,421,424,426,428,430,432,434,436,437],{"name":402,"class":6},"University of Alabama at Birmingham",{"name":404,"class":6},"University of British Columbia",{"name":406,"class":6},"University of Pittsburgh",{"name":380,"class":6},{"name":327,"class":6},{"name":410,"class":6},"Vanderbilt University Medical Center",{"name":40,"class":6},{"name":220,"class":6},{"name":414,"class":6},"Johns Hopkins University",{"name":416,"class":6},"University of Calgary",{"name":418,"class":6},"University of Colorado, Denver",{"name":420,"class":6},"Children's Hospital Los Angeles",{"name":422,"class":423},"National Institutes of Health (NIH)","NIH",{"name":425,"class":6},"Hydrocephalus Association",{"name":427,"class":6},"Penn State University",{"name":429,"class":423},"National Institute of Neurological Disorders and Stroke (NINDS)",{"name":431,"class":6},"Baylor College of Medicine",{"name":433,"class":6},"University of Florida",{"name":435,"class":6},"Orlando Health, Inc.",{"name":317,"class":6},{"name":168,"class":438},"UNKNOWN","100376161","phase-3-hcrn-endoscopic-versus-shunt-treatment-of-hydrocephalus-in-infants-100376161",false,"NCT04177914","HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants","Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants","ESTHI","Inclusion Criteria:\n\n1. Corrected age \\\u003C104 weeks and 0 days,\n\n   AND\n2. Child is ≥ 37 weeks post menstrual age,\n\n   AND\n3. Child must have symptomatic hydrocephalus, defined as:\n\n   Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \\>0.45, which approximates \"moderate ventriculomegaly\"), and at least one of the following:\n   * Head circumference \\>98th percentile for corrected age with either bulging fontanelle or splayed sutures\n   * Upgaze paresis\u002Fpalsy (sundowning)\n   * CSF leak\n   * Papilledema\n   * Tense pseudomeningocele or tense fluid along a track\n   * Vomiting or irritability, with no other attributable cause\n   * Bradycardias or apneas, with no other attributable cause\n   * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves\n\n   AND\n4. No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and\u002For external ventricular drains permissible)\n\nExclusion Criteria:\n\n1. Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR\n2. Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as:\n\n   * Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE\u002FTSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX\n   * Closure of one or both foramina of Monro\n   * Thick floor of third ventricle (≥ 3mm)\n   * Narrow third ventricle (\\\u003C5mm)\n   * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR\n3. Underlying condition with a high chance of mortality within 12 months; OR\n4. Hydrocephalus with loculated CSF compartments; OR\n5. Peritoneal cavity not suitable for distal shunt placement; OR\n6. Active CSF infection; OR\n7. Hydranencephaly; OR\n8. Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.","ALL","1 Day","104 Weeks",{"count":451,"type":452},176,"ESTIMATED","INTERVENTIONAL",[455],"PHASE3","Hydrocephalus is a potentially debilitating neurological condition that primarily affects babies under a year of age and has traditionally been treated by inserting a shunt between the brain and the abdomen. A newer endoscopic procedure offers hope of shunt- free treatment that may reduce complications over a child's life, but it is not clear if the endoscopic procedure results in similar intellectual outcome as shunt. Therefore, the investigators propose a randomized trial to compare intellectual outcome and brain structural integrity between these two treatments, to help families make the best treatment decision for their baby.",[458],"Hydrocephalus",[458,460,15,9,461,462],"Infants","endoscopic third ventriculostomy","choroid plexus cauterization","2025-06-05",{"date":465,"type":466},"2025-06-11","ACTUAL",{"date":468,"type":466},"2020-07-21",{"date":470,"type":452},"2027-08-31",{"name":5,"class":6},21]