Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT01284894
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2011-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esophageal High Resolution Manometry and Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients correctly diagnosed for esophageal motility disorder', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)', 'timeFrame': '24 hours'}, {'measure': 'Duration of examination and study analysis', 'timeFrame': 'day 0'}, {'measure': 'Cost of patient care within the 6 months following the manometry', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysphagia', 'Conventional manometry', 'High resolution manometry'], 'conditions': ['Dysphagia']}, 'referencesModule': {'references': [{'pmid': '26832656', 'type': 'RESULT', 'citation': 'Roman S, Huot L, Zerbib F, Bruley des Varannes S, Gourcerol G, Coffin B, Ropert A, Roux A, Mion F. High-Resolution Manometry Improves the Diagnosis of Esophageal Motility Disorders in Patients With Dysphagia: A Randomized Multicenter Study. Am J Gastroenterol. 2016 Mar;111(3):372-80. doi: 10.1038/ajg.2016.1. Epub 2016 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female older than 18 years\n* Patient with unexplained dysphagia\n* Patient without cause of dysphagia on eso-gastro-duodenal endoscopy\n* Patient referred for esophageal manometry\n* Patient with health insurance\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patient younger than 18 years\n* Allergy to one component of manometry catheter\n* Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry\n* Patient unable to give his consent or legally incompetent\n* Patient non qualified according to the investigator\n* Patient refusal or absence of informed consent signed\n* Concomitant participation to another study'}, 'identificationModule': {'nctId': 'NCT01284894', 'briefTitle': 'Esophageal High Resolution Manometry and Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia', 'orgStudyIdInfo': {'id': '2010.624/28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Conventional manometry', 'interventionNames': ['Device: Conventional manometry']}, {'type': 'EXPERIMENTAL', 'label': 'High resolution manometry', 'interventionNames': ['Device: High resolution manometry']}], 'interventions': [{'name': 'Conventional manometry', 'type': 'DEVICE', 'description': 'Conventional esophageal manometry', 'armGroupLabels': ['Conventional manometry']}, {'name': 'High resolution manometry', 'type': 'DEVICE', 'description': 'High resolution esophageal manometry', 'armGroupLabels': ['High resolution manometry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69437', 'city': 'Lyon', 'state': 'Lyon', 'country': 'France', 'facility': "Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Sabine ROMAN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Unité d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - 69437 Lyon Cedex 03- France"}, {'name': 'Stanislas BRULEY DES VARANNES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Hépato-Gastro-Entérologie - CHU Hôtel Dieu - Place A Ricordeau - 44093 Nantes Cedex - France"}, {'name': 'Franck ZERBIB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Hépato-Gastro-Entérologie - Hôpital Saint-André - 33075 Bordeaux Cedex - France"}, {'name': 'Guillaume GOURCEROL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen - 76031 Rouen Cedex - France'}, {'name': 'Silvana PERRETTA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pole Hépato- Digestif, Service de Chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - 1 place de l'Hôpital - 67091 Strasbourg cedex - France"}, {'name': 'Franck ROPERT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Hépato-Gastro-Entérologie - CHU Pontchaillou - Rue H. le Guillou - 35033 Rennes cedex - France"}, {'name': 'François MION, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Hépato-Gastro-Entérologie, Hôpital de la Croix-Rousse , 69317 Lyon"}, {'name': 'Benoit COFFIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier, 92700 Colombes"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}