Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT05080634
Status:
RECRUITING
Last Update Posted:
2021-10-18
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2021-10-04', 'lastUpdatePostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM)', 'timeFrame': '36 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peroral endoscopic myotomy', 'High-resolution esophageal manometry'], 'conditions': ['Achalasia', 'GERD']}, 'descriptionModule': {'briefSummary': 'Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated at a single center who had a complete GERD evaluation after POEM will be included in the study. Demographics, preoperative and follow-up data, results of functional studies and procedural data will be collected and analyzed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF)\n2. Achalasia patients who underwent POEM\n\nExclusion Criteria:\n\n1. Lack of written consent for participation in the study\n2. Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry'}, 'identificationModule': {'nctId': 'NCT05080634', 'briefTitle': 'Analysis of Prevalence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy', 'orgStudyIdInfo': {'id': '22042020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patients who underwent POEM', 'type': 'OTHER', 'description': 'chalasia patients were recruited from a single center. The pre- and postoperative assessments included Eckardt scores, GerdQ questionnaire, high-resolution esophageal manometry, esophagogastroscopy and pH monitoring.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna Chaber-Ciopińska, PhD', 'role': 'CONTACT', 'email': 'annachaber@op.pl', 'phone': '+48 225463044'}, {'name': 'Aleksandra Budnicka-Borkowicz, MD', 'role': 'CONTACT', 'email': 'aleksandra.budnicka-borkowicz@coi.pl', 'phone': '+48 791000890'}], 'facility': 'Maria Sklodowska-Curie Institute - Oncology Center', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Anna Chaber-Ciopińska, PhD', 'role': 'CONTACT', 'email': 'annachaber@op.pl', 'phone': '(+48) 225463044'}, {'name': 'Aleksandra Budnicka-Borkowicz, MD', 'role': 'CONTACT', 'email': 'aleksandra.budnicka-borkowicz@coi.pl', 'phone': '(+48) 791000890'}], 'overallOfficials': [{'name': 'Anna Chaber-Ciopińska, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Maria Sklodowska-Curie National Research Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}