[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658885":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":60,"collaborators":13,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":13,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":13,"studyType":74,"phases":75,"briefSummary":76,"conditions":77,"keywords":13,"overallStatus":86,"whyStopped":13,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and adverse events (AEs)","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Primary Objectives Evaluate the Efficacy of Nitrous Oxide Cryoballoon Ablation: To determine the clinical efficacy of nitrous oxide cryoballoon ablation in achieving complete eradication of duodenal adenomas in patients with Familial Adenomatous Polyposis (FAP) and Hereditary Non-Polyposis Colorectal Cancer (HNPCC). The primary endpoint will be the complete eradication of adenomas at 12 months post-procedure, confirmed by endoscopy and histology.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"EGD + CBA","EXPERIMENTAL","Endoscopy with Cryoballoon Ablation Treatment of Duodenal Adenomas",[27],"Procedure: Esophagogastroduodenoscopy",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"PROCEDURE","Esophagogastroduodenoscopy","Esophagogastroduodenoscopy with cryoballoon ablation will be performed every 3 months to a maximum of 5 procedures.",[23],[35],{"name":36,"affiliation":37,"role":38},"Marta Davila, MD","UT MD Anderson Cancer Center","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":13,"email":43},"CONTACT","713-563-4382","MDavila@mdanderson.org",[45],{"facility":37,"status":13,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Houston","Texas","77030","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-95.36327,29.76328,{"lat":55,"lon":54},[58,59],{"name":36,"role":41,"phone":42,"phoneExt":13,"email":43},{"name":36,"role":38,"phone":13,"phoneExt":13,"email":13},{"type":61,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100658885","prospective-study-to-assess-the-outcomes-of-nitrous-oxide-cryoablation-for-treatment-of-duodenal-adenomas-in-patients-with-hereditary-conditions-such-as-fap-hnpcc-100658885",false,"NCT07859514","Prospective Study To Assess The Outcomes Of Nitrous Oxide Cryoablation For Treatment Of Duodenal Adenomas In Patients With Hereditary Conditions Such As FAP, HNPCC","Eligibility Criteria\n\n* Participants aged 20-75 years.\n* Confirmed diagnosis of FAP or HNPCC.\n* Presence of flat duodenal adenomas confirmed by histology.\n* Ability to understand and willingness to sign an informed consent form.\n\nExclusion Criteria\n\n* Presence of invasive duodenal cancer.\n* Severe comorbidities that would contraindicate endoscopic procedures.\n* Allergy or intolerance to components of the nitrous oxide cryoballoon system.\n* Previous duodenal surgery affecting the study area.\n* Active gastrointestinal bleeding. Pregnancy","ALL","20 Years","75 Years",{"count":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[15],"To learn how well nitrous oxide cryoballoon ablation, a procedure that uses extreme cold to destroy abnormal tissue, works in treating flat duodenal adenomas (abnormal growths in the small intestine) in people with FAP or Lynch syndrome (HNPCC).",[78,79,80,81,82,83,84,85],"Prospective Study , Questionaires","Outcomes","Nitrous Oxide","Cryoablation","Duodenal Adenoma","Hereditary Conditions","FAP","HNPCC","NOT_YET_RECRUITING","2026-09-30",{"date":89,"type":90},"2026-10-05","ACTUAL",{"date":92,"type":73},"2027-03-03",{"date":94,"type":73},"2032-01-01",{"name":5,"class":6},1]