Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT01064895
Status:
TERMINATED
Last Update Posted:
2016-11-08
First Post:
2010-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2010-02-05', 'studyFirstSubmitQcDate': '2010-02-05', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Benephit', 'Acute Kidney Injury', 'Acute Renal Failure', 'Contrast Induced Nephropathy', 'Chronic Kidney Disease'], 'conditions': ['Acute Kidney Injury', 'Acute Renal Failure', 'Renal Failure Chronic Contrast Induced', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are planned to be used at participating sites are eligible for enrollment. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics will be able to (1) Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface information and overall customer satisfaction, and (3) Monitor post-marketing device performance and safety for ISO quality adherence.', 'detailedDescription': 'Acute kidney injury, or AKI, is a rapid decline in renal function characterized by a decrease in urine output and/or an increase in serum creatinine (Cr), and is associated with worsened clinical outcomes and increased healthcare costs. AKI may be caused by numerous factors including interruptions or perturbations of renal blood flow or toxins, and often these factors are extra-renal in origin. AKI diagnoses in hospitalized patients are over one million per year and are projected to continue to grow, due largely to the aging population and increasing numbers of medical and invasive procedures performed on the elderly and the ever-increasing prevalence of diabetes mellitus and its medical complications, as well as increasing awareness within the medical community.\n\nTreatment options for established acute kidney injury are limited and consist mainly of fluid and electrolyte balance (diuretics and/or IV fluids) supportive care up until the point that dialysis or other renal replacement therapy (RRT) is required. Despite the advent of newer drugs, more sophisticated RRT equipment, and increased awareness of the problem, little has changed relative to patient outcomes, which remain poor. Similarly, limited options exist in patients with known risk factors for AKI to prevent its development due to iatrogenic causes (e.g., major surgery, exposure to contrast media).\n\nTargeted Renal Therapy allows for direct delivery of therapeutically relevant doses of various pharmacological agents directly to the renal bed, potentially reducing dose limiting side effects of traditional IV therapy. With Targeted Renal Therapy, or TRT, the kidney can metabolize, conjugate, and/or clear a substantial portion of many agents immediately (known as the "renal first-pass" effect), reducing the amount that is returned to the systemic circulation via the renal veins, thus potentially reducing untoward side effects. While the existence of a renal first-pass effect has been hypothesized in the medical literature for some time, it has not been possible to take clinical advantage of this important physiological function prior to the advent of AngioDynamics\' TRT. Thus, TRT has the potential to offer an additional preventative or treatment opportunity in those patients at risk for AKI, or with established AKI, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic acute kidney injury for the patient. Also indicated in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization with the Benephit infusion systems is feasible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician-determined need for Benephit device/Targeted Renal Therapy\n* Age \\>=18 years\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Patients who are participating in another IRB approved research study that precludes simultaneous enrollment'}, 'identificationModule': {'nctId': 'NCT01064895', 'acronym': 'PROVIDE', 'briefTitle': 'Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Angiodynamics, Inc.'}, 'officialTitle': 'Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)', 'orgStudyIdInfo': {'id': '2008-CL0015 Revision C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active Cohort', 'description': 'Patients receiving the Benephit device and targeted renal therapy.', 'interventionNames': ['Device: Benephit catheter for Targeted Renal Therapy']}], 'interventions': [{'name': 'Benephit catheter for Targeted Renal Therapy', 'type': 'DEVICE', 'otherNames': ['Benephit CV,PV,XT Infusion Systems(K033569,K050205,K082163)'], 'description': 'Local physician-specified agent delivery to the kidneys bilaterally via the renal arteries using the Benephit infusion system.', 'armGroupLabels': ['Active Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cardiac & Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'HealthwoRx South Florida Research Solutions', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Bingham Memorial Hospital', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cardiology Associates of NW Indiana', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '41101', 'city': 'Ashland', 'state': 'Kentucky', 'country': 'United States', 'facility': "King's Daughters Medical Center", 'geoPoint': {'lat': 38.47841, 'lon': -82.63794}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Graves Gilbert Clinic', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Sahetya Medical Institute', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Western Kentucky Heart and Lung', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '42101', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Hospital & Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Joseph Health Center', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '17201', 'city': 'Chambersburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Chambersburg Hospital', 'geoPoint': {'lat': 39.93759, 'lon': -77.6611}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Cardiology PC', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angiodynamics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}