Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT03415893
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-resolution Esophageal Manometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004933', 'term': 'Esophageal Atresia'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patterns of High Resolution Manometry in teenagers with esophageal atresia', 'timeFrame': 'one day', 'description': 'Number of patients with patterns of complete aperistalsis, pressurization and distal esophageal contraction in High Resolution Manometry'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-resolution manometry', 'esophageal atresia', 'teenagers'], 'conditions': ['Esophageal Atresia']}, 'descriptionModule': {'briefSummary': 'EA is one of the most frequent birth defects, with an incidence of 1 in 3000 live births1. Until the 1950s, these patients had 100% mortality; nowadays, the survival rate is greater than 90%, and only those with associated severe malformations die1-5.\n\nType C EA (atresia of the esophageal proximal segment with tracheoesophageal fistula between the trachea and the distal segment) is the most common variant, since it is present in 85% of the cases6-8. There is evidence that the esophageal motor disorder present in these children is secondary to a congenital neuromuscular disorder and a postoperative disorder9-14. Patients that survive the operation have greater risk of developing gastroesophageal reflux disease (GERD), caused by anomalies in the esophageal motility and its resulting delay in the evacuation of acid of the esophageal lumen.\n\nThere was a hypothesis that suggested that motility alteration could contribute to dysphagia and to the high prevalence of gastroesophageal reflux in these patients15-18. Also, there were reports of a greater incidence of severe esophagitis with requirement of fundoplication, which shows a larger failure rate17-18. Esophageal dysmotility has been proved in children with EA through performance of conventional perfusion manometry.\n\nLemoine C et al described three motility alteration patterns with HRM in children with repaired EA. Said study allowed a more precise knowledge of segmental esophageal motility19. Currently, there are no reports exclusively made about teenagers with repaired EA that describe segmental esophageal motility with HRM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'teenagers with esophageal atresia and surgically repaired', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nteenagers of more than 12 years old, with repaired EA, orally fed during the last 6 months, with no history of esophageal blockage or dilations, who underwent a HREM\n\nExclusion Criteria:\n\n* patients under 12 years old'}, 'identificationModule': {'nctId': 'NCT03415893', 'briefTitle': 'High-resolution Esophageal Manometry', 'organization': {'class': 'OTHER', 'fullName': 'Hospital El Cruce'}, 'officialTitle': 'High-resolution Esophageal Manometry in Teenagers With Esophageal Atresia', 'orgStudyIdInfo': {'id': 'High-resolution manometry'}}, 'contactsLocationsModule': {'locations': [{'zip': '1888', 'city': 'San Juan Bautista', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital El Cruce', 'geoPoint': {'lat': -34.80896, 'lon': -58.27623}}], 'overallOfficials': [{'name': 'cecilia curvale', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital El Cruce'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital El Cruce', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'CECILIA CURVALE', 'investigatorAffiliation': 'Hospital El Cruce'}}}}