Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00931593
Status:
UNKNOWN
Last Update Posted:
2009-07-02
First Post:
2009-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008365', 'term': 'Manometry'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-01', 'studyFirstSubmitDate': '2009-07-01', 'studyFirstSubmitQcDate': '2009-07-01', 'lastUpdatePostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.'}], 'secondaryOutcomes': [{'measure': 'To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.'}, {'measure': 'To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transient lower esophageal sphincter relaxation', 'high resolution manometry', 'dentsleeve probe', 'healthy volunteers'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.\n\nThe gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.\n\nEsophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female between 18 and 60 years\n2. Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)\n3. Subject without any medication (except oral contraception)\n4. Subject without previous digestive surgery history (except appendicectomy)\n5. Capability to pass manometric probes through each nostril\n6. Subject with health insurance\n7. Written informed consent\n8. No participation to another study at the same time\n\nExclusion Criteria:\n\n1. Age under 18 years or upper 60\n2. Pregnant woman or lactation\n3. Incapability to give consent\n4. No written informed consent'}, 'identificationModule': {'nctId': 'NCT00931593', 'briefTitle': 'Transient Lower Esophageal Sphincter Relaxations and High Resolution Manometry', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.', 'orgStudyIdInfo': {'id': '2008.546/47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'volunteers', 'description': "This is a descriptive study to compare two techniques (manometry with perfused dentsleeve probe vs high resolution manometry for the identification of tLESr). Each subject is his own control.\n\nThe date of perfused manometry is randomized to avoid bias due to examinations' order.", 'interventionNames': ['Device: Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)']}], 'interventions': [{'name': 'Esophageal high resolution manometry associated or not with manometry with perfused Dentsleeve probe (as determined by randomization)', 'type': 'DEVICE', 'description': 'Visit V0 (day 0 - 2 to 14 days):\n\n* Subject selection\n* Obtaining of written informed consent\n\nVisit V1 (day 0):\n\n* Fasting subject\n* Randomization to determine the examination order\n* Esophageal high resolution manometry (Sierra Scientific Instruments, California CA) associated or not with manometry with perfused Dentsleeve probe (as determined by randomisation): 3-hour recording (1 hour fasting, ingestion of a 600-kcal liquid meal in 10 minutes, 2 hours post prandial)\n\nVisit V2 (day 0 + 1 day): Phone contact\n\nVisit V3 (day 0 + 2 to 7 days):\n\n* Same as V1\n\nVisit V4 (V3 + 1 day): Phone contact and end of the study', 'armGroupLabels': ['volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33075', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'ZERBIB Frank, MD', 'role': 'CONTACT', 'email': 'frank.zerbib@chu-bordeaux.fr', 'phone': '05 56 79 58 06'}, {'name': 'ZERBIB Frank, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital St André, CHU BORDEAUX', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69437', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ROMAN Sabine', 'role': 'CONTACT', 'email': 'sabine.roman@chu-lyon.fr', 'phone': '04 72 11 01 36'}, {'name': 'ROMAN Sabine, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'MION François, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Edouard Herriot - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '44093', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'BRULEY DES VARANNES Stanislas, MD', 'role': 'CONTACT', 'phone': '02 40 08 31 65'}, {'name': 'BRULEY DE VARANNES Stanislas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Hôtel Dieu, CHU NANTES', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'ROMAN Sabine, MD', 'role': 'CONTACT', 'email': 'sabine.roman@chu-lyon.fr', 'phone': '04 72 11 01 36'}], 'overallOfficials': [{'name': 'ROMAN Sabine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'MION François, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'BRULEY DES VARANNES Stanislas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU NANTES'}, {'name': 'ZERBIB Frank, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU BORDEAUX'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Sabine ROMAN', 'oldOrganization': 'Hospices Civils de Lyon'}}}}