Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT02905669
Status:
UNKNOWN
Last Update Posted:
2022-03-21
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004935', 'term': 'Esophageal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Esophago-gastric junction distensibility', 'timeFrame': 'The day of gastro-intestinal endoscopy'}], 'secondaryOutcomes': [{'measure': 'Esophageal distensibility', 'timeFrame': 'The day of gastro-intestinal endoscopy'}, {'measure': 'Pylorus distensibility', 'timeFrame': 'The day of gastro-intestinal endoscopy'}, {'measure': 'Esophageal contractile activity in response to distension', 'timeFrame': 'The day of gastro-intestinal endoscopy', 'description': 'distension volume for presence of esophageal repetitive contraction'}, {'measure': 'Side effects occurence', 'timeFrame': 'The day of gastro-intestinal endoscopy', 'description': 'Occurrence of pain, aspiration and vomiting'}, {'measure': 'Side effects occurence', 'timeFrame': 'The day after gastro-intestinal endoscopy', 'description': 'Occurrence of pain, aspiration and vomiting'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['distensibility', 'impedance planimetry', 'esophagus', 'esophago-gastric junction', 'pylorus'], 'conditions': ['Esophageal Dysfunction', 'Pylorus Dysfunction']}, 'descriptionModule': {'briefSummary': 'Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject older than 18 years and younger than 80 years\n* Subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or submucosal dissection\n* Subject with health insurance\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient younger than 18 years or older than 80 years\n* Pregnancy or breast feeding\n* Previous history of esophago-gastric surgery or vagotomy\n* Previous history of Parkinson disease or diabetes mellitus\n* Contra-indication to upper gastro-intestinal endoscopy\n* Esophageal varices\n* Esophageal diameter smaller than 5 mm\n* Contra-indication to general anesthesia\n* Hiatal hernia greater than 3 cm on endoscopy\n* Esophageal or gastric cancer otherwise than superficial lesion with indication of submucosal dissection\n* Typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or gastroesophageal reflux disease (GERD)-Q score greater or equal to 8\n* Nausea, vomiting or epigastric pain\n* Dysphagia with Sydney score greater ou equal to 50\n* Incapability to give consent\n* No written informed consent\n* Participation to another study at the same time'}, 'identificationModule': {'nctId': 'NCT02905669', 'acronym': 'NormaFLIP', 'briefTitle': 'Normal Values for Esophageal and Pyloric Impedance Planimetry Under General Anesthesia (NormaFLIP)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Measurement of Contractile Activity and Distensibility of the Esophago-gastric Junction, of the Esophagus and of the Pylorus: Normal Values in Controls Under General Anesthesia (NormaFLIP Study)', 'orgStudyIdInfo': {'id': '69HCL16_0457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EndoFLIP', 'description': 'Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device.', 'interventionNames': ['Device: EndoFLIP']}], 'interventions': [{'name': 'EndoFLIP', 'type': 'DEVICE', 'description': 'Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device', 'armGroupLabels': ['EndoFLIP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69437', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sabine ROMAN, MD, PhD', 'role': 'CONTACT', 'email': 'sabine.roman@chu-lyon.fr', 'phone': '+33472110146'}, {'name': 'Sabine ROMAN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Sabine ROMAN, MD, PhD', 'role': 'CONTACT', 'email': 'sabine.roman@chu-lyon.fr', 'phone': '+33472110146'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}