[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03654066":3,"trial-entities:NCT03654066":89,"trial-summary:NCT03654066":92},{"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":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":51,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":15,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":69,"locations":72,"central_contacts":82,"overall_officials":83,"references":87,"see_also_links":88},"NCT03654066","181420","Botox or Botox With Esophageal Dilation in Patients With Achalasia","Prospective Single-Blinded Randomized Controlled Trial Comparing Botox or Botox With Esophageal Dilation in Patients With Achalasia","ENROLLING_BY_INVITATION","2026-08-01","2026-05","2026-08-03","2019-05-13","Vanderbilt University Medical Center","OTHER",null,"Achalasia is a rare esophageal motility disorder. Treatment of achalasia is aimed toward palliation of symptoms. These include botox injections to the lower esophageal sphincter (LES), pneumatic dilation, surgical myotomy, and per-oral endoscopic myotomy (POEM). Botox injections are frequently used for patients that have significant comorbidities. The primary aim of this study is to assess symptomatic response of patient with achalasia to esophageal dilation and botox injection to the LES compared to standard therapy of only botox injection.",[18],"Achalasia",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE4",{"count":25,"type":26},50,"ESTIMATED",[28,37,42,46],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":35},"DRUG","Botulinum toxin type A","Botox injection in the LES",[33,34],"Botulinum toxin","Botulinum toxin and dilation",[36],"Botox",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DEVICE","Endoscope balloon dilator","Distal esophageal dilation",[34],{"type":14,"name":43,"description":44,"armGroupLabels":45},"Patient reported outcomes","Subjects will complete two patient reported outcome measures (Eckardt and MADS).",[33,34],{"type":47,"name":48,"description":49,"armGroupLabels":50},"DIAGNOSTIC_TEST","Barium esophagram","Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium",[33,34],[52],{"measure":53,"description":54,"timeFrame":55},"dysphagia score","Dysphagia score as measured by patient reported outcomes will be used to compare the two groups. The scale runs from 0 (no symptoms) to 100 (severe symptoms).","12 months",[],"ALL","18 Years",false,{"inclusion":61,"exclusion":64,"raw_text":68},[62,63],"Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM","Patient undergoing routine care upper endoscopy for achalasia",[65,66,67],"Less than 18 years old","Previous surgery for reflux or peptic ulcer disease","Significant medical conditions possibly placing subjects at risk to undergo endoscopy","Inclusion Criteria:\n\n* Adults with known diagnosis of achalasia who are NOT candidates for definitive therapy with pneumatic dilation, surgical myotomy, or POEM\n* Patient undergoing routine care upper endoscopy for achalasia\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Previous surgery for reflux or peptic ulcer disease\n* Significant medical conditions possibly placing subjects at risk to undergo endoscopy",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Vanderbilt University Medical Center Endoscopy Laboratory","Nashville","Tennessee","37232","United States",{"lat":80,"lon":81},36.16589,-86.78444,[],[84],{"name":85,"affiliation":13,"role":86},"Dhyanesh Patel, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":91},[18],[],{"nct_id":4,"found":59,"summary":15,"prompt_version":15}]