Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT00737802
Status:
TERMINATED
Last Update Posted:
2019-02-22
First Post:
2008-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D006356', 'term': 'Heartburn'}], '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'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Was not able to recruit the total anticipated number of subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2008-08-18', 'studyFirstSubmitQcDate': '2008-08-19', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure at the gastric sling and clasp fibers', 'timeFrame': '5 years', 'description': 'esophageal and gastroesophageal junction Pressure at the gastric sling and clasp fibers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'Heartburn', 'Esophageal reflux', 'Barretts esophagus', 'Normal subjects'], 'conditions': ['GERD', 'Barretts Esophagus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n* To study the components of the gastroesophageal junction high-pressure zone individually and as a group, by pharmacologically eliminating or accentuating the pressure profile generated by the smooth muscle components.\n* To differentiate the gastric sling fibers from the clasp fibers based on the spatial orientation of these muscle groups.', 'detailedDescription': 'The purpose of this research study is to examine and evaluate a part of the digestive system (gastrointestinal tract). The specific part the study team will look at is called the "lower esophageal sphincter complex." This complex is located where the esophagus (food pipe) meets the top of the stomach. The lower esophageal sphincter complex involves a group of muscles, and the study team hopes to better understand how they work.\n\nThe study team hopes that, by studying the lower esophageal sphincter complex, it may be possible to discover how it functions and what causes it to fail. When a complex fails, this can lead to reflux and heartburn. So learning more about the lower esophageal complex may help doctors\' better treat future patients with reflux problems.\n\nWe plan to study these functions in normal control subjects, in patients with GERD (heartburn symptoms), and in patients with Barrett\'s esophagus (a change in the lining of the esophagus due to chronic reflux). The doctor performing the study procedure has previous experience with and is skilled in performing these procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal control subjects without GERD and patients with GERD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for GERD patients are:\n\n* Symptomatic heartburn\n* Regurgitation\n* Chest pain or water brash\n\nExclusion Criteria:\n\nExclusion criteria for normal volunteers include:\n\n* Medications-Subjects on any medication which could effect the gastroesophageal junction high-pressure zone will be excluded, this includes use of antacids, H2 blockers, proton pump inhibitors, prokinetic agents, erythromycin type antibiotics and anticholinergics.\n* GI symptoms, conditions and disorders\n\nIn addition exclusion criteria will include a history of:\n\n* Esophagitis\n* Gastrointestinal symptoms such as abdominal pain\n* Heartburn\n* Reflux\n* Regurgitation\n* Chest pain\n* Difficulty swallowing\n* Pain on swallowing\n* Dysphagia\n* Abdominal surgery involving the stomach or esophagus\n* Nausea or vomiting\n* Diabetes\n* Scleroderma\n* Esophageal motility disorders\n* Non cardiac chest pain\n* Achalasia and current pregnancy.'}, 'identificationModule': {'nctId': 'NCT00737802', 'briefTitle': 'In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'In Vivo Anatomy, Physiology, Mechanics and Function of the Lower Esophageal Sphincter', 'orgStudyIdInfo': {'id': 'R01DK059500', 'link': 'https://reporter.nih.gov/quickSearch/R01DK059500', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Control', 'description': 'Normal control subjects are the participants with no history of GERD, no signs and symptoms of GERD'}, {'label': 'GERD Patients', 'description': 'GERD patients are those with history of GERD, signs and symptoms of GERD and selected signs and symptoms of GERD in the questionnaire.'}, {'label': "Barrett's patients", 'description': "Barrett's patients are those participants who in addition to all the qualities of GERD patients have long standing history of GERD and mucosal changes in the esophagus."}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'LIJ Medical Center- NSLIJ Health System', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Larry S Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Feinstein Institute for Medical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Larry Miller', 'investigatorAffiliation': 'Northwell Health'}}}}