Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT00405834
Status:
COMPLETED
Last Update Posted:
2008-07-04
First Post:
2006-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of the Envision® Surface
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-01', 'studyFirstSubmitDate': '2006-11-28', 'studyFirstSubmitQcDate': '2006-11-28', 'lastUpdatePostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pressure Ulcers'], 'conditions': ['Pressure Ulcers']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the clinical safety and effectiveness of the Envision® surface.', 'detailedDescription': 'This study is to evaluate the clinical safety and effectiveness of the Envision® surface placed on the TotalCare® frame in pressure ulcer prevention and management, patient comfort, and staff acceptance in the critical care environment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject weighs between 70 and 400 pounds Subject to remain on Envision Surface for at least 3 days Subject at risk for pressure ulcers (Braden Score \\< 14) or has existing ulcer of any stage Subject is able to provide voluntary consent\n\nExclusion Criteria:\n\n* Subject requires pulmonary treatment surface Subject declines consent'}, 'identificationModule': {'nctId': 'NCT00405834', 'briefTitle': 'A Pilot Study of the Envision® Surface', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hill-Rom'}, 'officialTitle': 'A Pilot Study of the Envision® Surface in a Patient Population at High Risk for or Who Have Pressure Ulcers: Evaluation of Pressure Ulcer Incidence, Changes in Existing Pressure Ulcers, Clinical Staff Satisfaction and Patient Comfort', 'orgStudyIdInfo': {'id': 'CR-0065'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Envision® Patient Support System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Betsy Fisher, RN, CWOCN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sinai Hospital of Baltimore / Lifebridge Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hill-Rom', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gordon MacFarlane, PhD, Director of Clinical Research', 'oldOrganization': 'Hill-Rom'}}}}