Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT02345603
Status:
UNKNOWN
Last Update Posted:
2019-04-24
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2015-01-19', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure levels', 'timeFrame': '2 months', 'description': '24 hour mean ambulatory blood pressure levels before and 2 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Levels of epinephrine and nor-epinephrine in urine', 'timeFrame': 'before and 2 months after surgery', 'description': 'Collection of urine for analyses of stress hormones'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.', 'detailedDescription': 'Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During the surgery the renal arteries at both sides are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Renal arterial blood flow is checked by Doppler after the freezing procedure, during the surgery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in 24h ambulatory blood pressure levels and of course safety parameters such as creatinine levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned prophylactic surgery for abdominal aortic aneurysm\n\nExclusion Criteria:\n\n* hypotension,\n* inability to understand study protocol'}, 'identificationModule': {'nctId': 'NCT02345603', 'acronym': 'PRASDEN', 'briefTitle': 'Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy During Open Surgery for Aortic Aneurysm', 'orgStudyIdInfo': {'id': '2014/45-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryo-therapy', 'description': 'Cryo-therapy of renal arteries', 'interventionNames': ['Procedure: Cryo-therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention in renal arteries'}], 'interventions': [{'name': 'Cryo-therapy', 'type': 'PROCEDURE', 'description': 'Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery', 'armGroupLabels': ['Cryo-therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'University Hospital of Linkoping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD professor Head of internal medicine', 'investigatorFullName': 'Fredrik H Nystrom', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}