Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-26 @ 12:49 PM
Study NCT ID:
NCT01112150
Status:
UNKNOWN
Last Update Posted:
2010-04-28
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Normatec Pump for Relief of Leg Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-27', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '5 days', 'description': 'The weight loss during the pumping pariod is related to fluid loss from edematous legs.'}], 'secondaryOutcomes': [{'measure': 'Leg circumference', 'timeFrame': '5 Days', 'description': 'The leg circumference will be measured before and after each pumping session to determine the effectiveness of the pumping.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Edema', 'Heart failure', 'Pulmonary hypertension', 'Edema in legs'], 'conditions': ['Edema', 'Heart Failure', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).\n* documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (\\> 35 mmHg) is expected in such cases.\n\nExclusion Criteria:\n\n* patients in sepsis,\n* hemodynamically unstable,\n* during an acute attack of pulmonary edema,\n* with renal failure (creatinine \\> 2 mg%),\n* with DVT,\n* psychiatric or noncompliant patients, and\n* patients who will not sign the informed consent form will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT01112150', 'briefTitle': 'Effect of Normatec Pump for Relief of Leg Edema', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes', 'orgStudyIdInfo': {'id': '0063-09-HYMC-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pumping group', 'description': 'Patients in this arm will get a pumping session 2-3 times a day .', 'interventionNames': ['Device: NormaTec Pump']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No pumping', 'description': 'These patients will not receive pumping but only classical treatment clinically indicated (diuretics, oxygen, Digoxin, Nitrates, ACE inhibitors etc, as necessary)', 'interventionNames': ['Device: NormaTec Pump']}], 'interventions': [{'name': 'NormaTec Pump', 'type': 'DEVICE', 'description': 'Normatec Pump', 'armGroupLabels': ['No pumping', 'Pumping group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'David S Blondheim, MD', 'role': 'CONTACT', 'phone': '97246304488'}, {'name': 'David S. Blondheim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hille Yaffe Medical Ceter', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'David S. Blondheim, MD', 'role': 'CONTACT', 'phone': '97246304488'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'David S. Blondheim', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}