Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-03-30 @ 4:23 PM
Study NCT ID:
NCT01405469
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2011-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endoscopic Peroral Myotomy for Treatment of Achalasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 't.roesch@uke.de', 'phone': '+49 40 7410 50098', 'title': 'Prof. Dr. Thomas Rösch, Principal Investigator', 'organization': 'University Hospital Hamburg-Eppendorf'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 days after POEM', 'description': '1 cm superficial ulcer (Forrest III) at the cardia', 'eventGroups': [{'id': 'EG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'treatment failure', 'notes': 'eckhardt score 9 three months after POEM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': '1 cm superficial ulcer (Forrest III)', 'notes': 'a 1 cm superficial ulcer (Forrest III) at the cardia was detected on routine EGD, 2 days after POEM.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ulcer in the distal esophagus', 'notes': 'retrosternal pain 3 weeks after POEM. EGD demonstrated an ulcer in the distal esophagus(FIII). The ulcer was clipped', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '9.016200316', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'manometry at 3 month after therapy', 'description': 'esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reflux Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment', 'description': 'Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'title': 'symptom relief 3 months after treatment', 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.217355783', 'groupId': 'OG000'}]}]}, {'title': 'eckhardt score baseline', 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.28', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-7.44', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.66', 'groupDescription': "this pilot study was created ro evaluate sample size for the following multicenter study, based on manometric outcomes. Mean values between baseline and follow-up were compared using Student ' s t -test for paired samples. P values less then 0.05, two-sided, were considered significant.R 2.13.1(R Development Core Team (2011). Subgroups (partial vs. complete myotomy) were compared using an analysis of variance test adjusted for initial values.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '3 months after treatment', 'description': 'eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(\\>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.', 'unitOfMeasure': 'Eckardt Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'procedure to 3 months post procedure', 'description': 'procedure-related adverse events per protocol', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medication 3 Months After POEM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'proton pump inhibitor (PPI) use at 3 months after POEM procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration Time Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'spread': '37.48238475', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'procedure', 'description': 'duration time of POEM procedures in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.'}, {'type': 'SECONDARY', 'title': 'Days Duration Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5625', 'spread': '0.892094913', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'days of hospitalization for POEM procedure, an average of 4 days', 'description': 'participants were followed for the duration of hospital stay, an average of 4 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.'}, {'type': 'SECONDARY', 'title': 'cm Myotomy Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '2.704933764', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'POEM procedure', 'description': 'myotomy length in cm', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'POEM Patients', 'description': 'pilot study, first 16 patients who received POEM for treatment of achalasia'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months after treatment', 'description': 'eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(\\>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals.', 'unitOfMeasure': 'percentage of treated patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'POEM Patients', 'description': 'pilot group of achalasia patients who received POEM Treatment: Endoscopic Myotomy of the Lower Esophageal Sphincter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients with symptomatic achalasia', 'preAssignmentDetails': '16 patients were included as per protocol, no patient was lost during follow-up over a 2 year period'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'POEM Patients', 'description': 'pilot study, first 16 patients who received POEM for treatment of achalasia'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '16.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-06', 'studyFirstSubmitDate': '2011-05-26', 'resultsFirstSubmitDate': '2014-09-04', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-01', 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3', 'timeFrame': '3 months after treatment', 'description': 'eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(\\>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms.'}], 'secondaryOutcomes': [{'measure': 'mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure', 'timeFrame': 'manometry at 3 month after therapy', 'description': 'esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure'}, {'measure': 'Number of Participants With Reflux Symptoms', 'timeFrame': 'during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment', 'description': 'Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment'}, {'measure': 'Number of Participants With Procedure-related Adverse Events', 'timeFrame': 'procedure to 3 months post procedure', 'description': 'procedure-related adverse events per protocol'}, {'measure': 'Medication 3 Months After POEM', 'timeFrame': '3 months', 'description': 'proton pump inhibitor (PPI) use at 3 months after POEM procedure'}, {'measure': 'Duration Time Procedure', 'timeFrame': 'procedure', 'description': 'duration time of POEM procedures in minutes'}, {'measure': 'Days Duration Hospitalization', 'timeFrame': 'days of hospitalization for POEM procedure, an average of 4 days', 'description': 'participants were followed for the duration of hospital stay, an average of 4 days'}, {'measure': 'cm Myotomy Length', 'timeFrame': 'POEM procedure', 'description': 'myotomy length in cm'}, {'measure': 'Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment', 'timeFrame': '3 months after treatment', 'description': 'eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. "with every meal" giving 3 points," daily" (2 points), "sometimes" (1 Point) or "no" (0 Points), as well as weight loss,(\\>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Achalasia', 'Heller myotomy', 'Dysphagia', 'Peroral Endoscopic Myotomy'], 'conditions': ['Achalasia']}, 'referencesModule': {'references': [{'pmid': '20354937', 'type': 'BACKGROUND', 'citation': 'Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.'}, {'pmid': '22068665', 'type': 'RESULT', 'citation': 'von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.'}], 'seeAlsoLinks': [{'url': 'http://www.uke.de/kliniken/endoskopie/index.php', 'label': 'University Hospital Hamburg-Eppendorf, Endoscopy Department'}]}, 'descriptionModule': {'briefSummary': 'This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.', 'detailedDescription': 'This pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in Europe.\n\n16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. Main outcome measurement is the eckhardt symptom score 3 month after therapy.\n\nPrimary outcome:\n\n-eckhardt symptom score 3 month after therapy.\n\nSecondary outcomes:\n\n* Lower esophageal sphincter pressure at 3 month after therapy.\n* Reflux symptoms at 3 month after therapy.\n\nFor this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophagal-gastro-duodenoscopy) and age greater than 18 years. Previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion.\n\nA forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis\n* persons of age \\> 18 years with medical indication for surgical myotomy or Endoscopic balloon dilatation\n* Signed written informed consent.\n\nExclusion criteria:\n\n* Patients with previous surgery of the stomach or esophagus\n* Patients with known coagulopathy\n* Previous achalasia-treatment with surgery\n* Patients with liver cirrhosis and/or esophageal varices\n* Active esophagitis\n* Eosinophilic esophagitis\n* Barrett's esophagus\n* Pregnancy\n* Stricture of the esophagus\n* Malignant or premalignant esophageal lesion\n* Candida esophagitis\n* Hiatal hernia \\> 2cm"}, 'identificationModule': {'nctId': 'NCT01405469', 'acronym': 'POEM', 'briefTitle': 'Endoscopic Peroral Myotomy for Treatment of Achalasia', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Endoscopic Peroral Myotomy for Treatment of Achalasia: Pilot Study', 'orgStudyIdInfo': {'id': 'UKE Hamburg Endoscopy PV3725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peroral Endoscopic Myotomy', 'description': 'Patients with achalasia who are designed to either get balloon dilatation or have botulinum toxin injection, or to have surgical intervention (Heller myotomy)for treatment', 'interventionNames': ['Other: Peroral Endoscopic Myotomy']}], 'interventions': [{'name': 'Peroral Endoscopic Myotomy', 'type': 'OTHER', 'description': 'A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips', 'armGroupLabels': ['Peroral Endoscopic Myotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf, Klinik für Interdisziplinäre Endoskopie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Thomas Roesch, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}