Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-01-01 @ 1:08 PM
Study NCT ID:
NCT06336850
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'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': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Portal Pressure Gradient Measurements from Hepatic and Portal Veins', 'timeFrame': '2 years', 'description': 'A catheter is inserted into the hepatic vein before hepatic venous pressure and portal vein pressure are recorded'}], 'secondaryOutcomes': [{'measure': 'Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension', 'timeFrame': '2 years', 'description': 'Statistical tests to determine relationship between portal pressure gradient measurements and portal hypertension'}, {'measure': 'Clinical significance between portal pressure gradient measurement and portal hypertension', 'timeFrame': '2 years', 'description': 'Presence of varices, hypertensive gastropathy, or thrombocytopenia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies.', 'detailedDescription': 'Patients undergoing EUS-guided liver biopsy may qualify to participate in this study. The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS- Portal Pressure Gradient Measurement (PPGM) in patients with liver disease referred for EUS-guided liver biopsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Age 18 years or older\n* Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy\n* History of liver disease or suspected cirrhosis and considered for PPGM\n\nEXCLUSION CRITERIA\n\n* Patient is less than 18 or greater than 85 years of age\n* Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study\n* Patient is unwilling or unable to sign and date the informed consent\n* Patient for whom endoscopic procedures are contraindicated.'}, 'identificationModule': {'nctId': 'NCT06336850', 'briefTitle': 'Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement', 'orgStudyIdInfo': {'id': '069.GID.2020.D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements', 'interventionNames': ['Procedure: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement']}], 'interventions': [{'name': 'Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement', 'type': 'PROCEDURE', 'description': 'The endoscopic ultrasound (EUS)-guided 25G fine needle aspirate (FNA) needle procedure is a straightforward minimally invasive technique for direct portal pressure measurements.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Prashant Kedia, MD', 'role': 'CONTACT'}], 'facility': 'Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Crystee Cooper, DHEd', 'role': 'CONTACT', 'email': 'clinicalresearch@mhd.com', 'phone': '214-947-1280'}, {'name': 'Zaid Haddadin, MS', 'role': 'CONTACT', 'email': 'clinicalresearch@mhd.com', 'phone': '214-947-1280'}], 'overallOfficials': [{'name': 'Prashant Kedia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}