Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-27 @ 10:34 AM
Study NCT ID:
NCT01558895
Status:
UNKNOWN
Last Update Posted:
2012-03-21
First Post:
2012-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2012-03-18', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ascites pressure', 'timeFrame': '30 min', 'description': 'use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infrared ray heat treatment', 'liver cirrhosis', 'refractory ascites'], 'conditions': ['Liver Cirrhosis', 'Refractory Ascites']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the treatment. Clinical symptoms were also observed simultaneously.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* aged 18\\~60 years\n* inpatient\n* Diagnosed with liver cirrhosis and liver stubborn ascites.\n\nExclusion Criteria:\n\n* Severe problems in other vital organs(e.g.the heart,renal or lungs).\n* combined with malignant tumour.\n* combined with endocrine diseases.\n* combined with high fever.\n* infected with the AIDS virus'}, 'identificationModule': {'nctId': 'NCT01558895', 'briefTitle': 'Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Foshan"}, 'officialTitle': 'Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites', 'orgStudyIdInfo': {'id': 'FS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional Treatment and Infrared ray heat treatment group', 'description': 'conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.', 'interventionNames': ['Radiation: Infrared ray heat treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional treatment group', 'description': 'conventional treatment consist of antiviral drugs, lowering aminotransferase and jaundice medicine.', 'interventionNames': ['Other: conventional treatment']}], 'interventions': [{'name': 'Infrared ray heat treatment', 'type': 'RADIATION', 'description': 'Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy.', 'armGroupLabels': ['Conventional Treatment and Infrared ray heat treatment group']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': 'Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.', 'armGroupLabels': ['conventional treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '528000', 'city': 'Foshan', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yinong Ye, doctor', 'role': 'CONTACT', 'email': 'yinongye@163.com', 'phone': '13826065501'}], 'facility': "The first people's hospital of Foshan", 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}], 'overallOfficials': [{'name': 'Yinong Ye, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Foshan"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chief', 'investigatorFullName': 'Yinong Ye', 'investigatorAffiliation': "First People's Hospital of Foshan"}}}}