[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02770859":3,"trial-entities:NCT02770859":79,"trial-summary:NCT02770859":82},{"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":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":21,"healthy_volunteers":41,"eligibility_criteria":42,"std_ages":46,"locations":49,"central_contacts":59,"overall_officials":60,"references":64,"see_also_links":78},"NCT02770859","1410540149","Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository","ENROLLING_BY_INVITATION","2040-01-31","2026-02","2026-02-18","2014-10-16","Indiana University","OTHER",false,"POEM (Per-Oral endoscopic myotomy (creating a muscle \\[esophagus\\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \\& sphincter of the LES for the treatment of achalasia.","Achalasia is a disease of the muscle of the esophagus (food tube) \\& means \"a failure to relax.\" The esophagus consists of 3 parts: the first part (uppermost part) is the upper esophageal sphincter (UES). The UES is a specialized ring of muscle which separates the esophagus from the throat, \\& prevents food in the second part (body) of the esophagus from regurgitating into the throat. The third part of the esophagus (lower esophageal sphincter \\[LES\\]) also consists of a specialized ring of muscle which separates the body of the esophagus from the stomach, \\& prevents food \\& acid from regurgitating into the body of the esophagus. When achalasia is present, patients experience dysphasia (difficulty swallowing food, \\& \\[sometimes\\] liquids), chest pain \\& can experience recurrent pneumonia \\& loss of weight.\n\nCurrent treatments for achalasia include oral medications (calcium channel blockers) to relax the LES (difficult to swallow pill\u002Fcapsule), dilation (stretching) of the LES, (temporary relief) \\& Esophagomyotomy (general surgery to cut the LES).\n\nPOEM (Per-Oral endoscopic myotomy (creating a muscle \\[esophagus\\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \\& sphincter of the LES for the treatment of achalasia.",[18],"Achalasia",[18],"OBSERVATIONAL",null,[],{"count":24,"type":25},5000,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"otherNames":31},"PROCEDURE","POEM (Per Oral Endoscopic Myotomy)","Per-Oral endoscopic myotomy (creating a muscle \\[esophagus\\] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle \\& sphincter of the LES for the treatment of achalasia",[32],"POEM",[34],{"measure":35,"description":36,"timeFrame":37},"Improved Eckardt Score","Consists of 4 questions used to characterize the severity of achalasia. The questions include symptoms related to dysphagia, chest pain, regurgitation, and weight loss. Each question is assigned a score from 0 to 3 based on the patient's self reported response.\n\nThe overall score ranges from 0-12, with anything less than 3 meaning no active symptoms, and anything higher than a 3 suggestive of active symptoms.","5 years",[],"ALL","18 Years",true,{"inclusion":43,"exclusion":44,"raw_text":45},[],[],"Inclusion Criteria:\n\n18 years of age Referral for the treatment of Achalasia\n\nExclusion Criteria:\n\nLess than 18 years of age; Absence of Achalasia",[47,48],"ADULT","OLDER_ADULT",[50],{"facility":51,"city":52,"state":53,"zip":54,"country":55,"geoPoint":56},"Indiana University Hospital","Indianapolis","Indiana","46202-5121","United States",{"lat":57,"lon":58},39.76838,-86.15804,[],[61],{"name":62,"affiliation":12,"role":63},"John M DeWitt, M.D.","PRINCIPAL_INVESTIGATOR",[65,69,72,75],{"pmid":66,"type":67,"citation":68},"41051511","DERIVED","DeWitt J, Stainko S, Perkins A, Rosenheck M, Al-Haddad M. Impact of prior endoscopic or surgical interventions on clinical outcomes after peroral endoscopic myotomy for achalasia. Surg Endosc. 2026 Jan;40(1):174-181. doi: 10.1007\u002Fs00464-025-12258-3. Epub 2025 Oct 6.",{"pmid":70,"type":67,"citation":71},"36509112","Jacobs CC, Al-Haddad M, Stainko S, Perkins A, DeWitt JM. Prevalence and impact of opioid use in patients undergoing peroral endoscopic myotomy. Gastrointest Endosc. 2023 Apr;97(4):655-663.e2. doi: 10.1016\u002Fj.gie.2022.12.006. Epub 2022 Dec 9.",{"pmid":73,"type":67,"citation":74},"35467562","DeWitt JM, Kessler WR, Wo JM, Stainko S, Perkins A, Dickason D, Al-Haddad MA, Siwiec R. Symptom Association for Gastroesophageal Reflux Disease by pH Monitoring After Peroral Endoscopic Myotomy. Am J Gastroenterol. 2022 Aug 1;117(8):1316-1319. doi: 10.14309\u002Fajg.0000000000001801. Epub 2022 Apr 25.",{"pmid":76,"type":67,"citation":77},"34979118","DeWitt JM, Siwiec R, Kessler WR, Wo JM, Stainko S, Picklesimer Doyle M, Perkins A, Dickason D, Al-Haddad MA. Comparison of functional lumen imaging probe and high-resolution manometry to assess response after peroral endoscopic myotomy. Gastrointest Endosc. 2022 May;95(5):855-863. doi: 10.1016\u002Fj.gie.2021.12.029. Epub 2022 Jan 1.",[],{"nct_id":4,"conditions":80,"biomarkers":81},[18],[],{"nct_id":4,"found":14,"summary":21,"prompt_version":21}]