Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-27 @ 3:31 AM
Study NCT ID:
NCT04593693
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Determine performance satisfaction of dressing components on periwound', 'timeFrame': 'Up to 4 week study duration', 'description': 'A weekly staff satisfaction survey on the ability to maintain dressing seal will be obtained from the wound clinic staff members to determine performance satisfaction of dressing components on periwound on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)'}], 'primaryOutcomes': [{'measure': 'Goal of therapy: Change in wound volume', 'timeFrame': 'Up to 4 week study duration', 'description': 'Wound measurements will be performed each week and length, width and depth of the wound measured during treatment until goal of the therapy is reached'}, {'measure': 'Goal of therapy: Change in size of the tunneling area', 'timeFrame': 'Up to 4 week study duration', 'description': 'Wound measurements will be performed each week and the tunneling of the wound measured during treatment until goal of the therapy is reached'}, {'measure': 'Goal of therapy: Change in size of undermining', 'timeFrame': 'Up to 4 week study duration', 'description': 'Wound measurements will be performed each week and the undermining of the wound measured during treatment until goal of the therapy is reached'}, {'measure': 'Goal of therapy: Change in amount of slough', 'timeFrame': 'Up to 4 week study duration', 'description': 'Wound measurements will be performed each week and the amount of slough measured during treatment until goal of the therapy is reached'}, {'measure': 'Goal of therapy: Change in granulation tissue', 'timeFrame': 'Up to 4 week study duration', 'description': 'Wound measurements will be performed each week and the amount of granulation tissue measured during treatment until goal of the therapy is reached'}, {'measure': 'Goal of therapy: Change in edema/periwound swelling', 'timeFrame': 'Up to 4 week study duration', 'description': 'Wound measurements will be performed each week and the presence of edema determined during treatment until goal of the therapy is reached'}, {'measure': 'Goal of therapy: The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft', 'timeFrame': 'Up to 4 week study duration', 'description': 'Wound measurements will be performed each week and the wound bed visually determined during treatment until goal of the therapy is reached'}], 'secondaryOutcomes': [{'measure': 'Evaluate the ease of use from clinicians', 'timeFrame': 'Up to 4 week study duration', 'description': 'A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine ease of use on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)'}, {'measure': 'Evaluate overall satisfaction from clinicians', 'timeFrame': 'Up to 4 week study duration', 'description': 'A weekly staff satisfaction survey will be obtained from the wound clinic staff members to determine overall satisfaction with the device on a scale from higher to worse score with four values (more satisfied, satisfied, neutral, less satisfied)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Negative Pressure Wound Therapy', 'Invia Motion'], 'conditions': ['Diabetic Foot Ulcer', 'Pressure Injury', 'Pressure Ulcer', 'Surgical Wound', 'Acute Wound', 'Traumatic Wound', 'Dehiscence', 'Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.', 'detailedDescription': 'The primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the Medela Invia Motion Endure NPWT system during 4-week study duration.\n\n\\* Goal of therapy will be defined by the physician according to initial assessment:\n\nEndpoints (dependent on goal of therapy):\n\n* Decrease in wound volume\n* Decrease in size of the tunneling area\n* Decrease in size of undermining\n* Decrease in amount of slough\n* Increase in granulation tissue\n* Decrease in edema/periwound swelling\n* The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.\n\n\\*\\*Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\\*\\*'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects ≥18 years of age.\n* Signed, informed consent by patient or LAR\n* Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema\n* Patient is comfortable (e.g. not in pain)\n* Patient is willing and able to adhere to treatment protocol.\n\nExclusion Criteria:\n\n* Patient not willing to comply with follow up (f/u) clinic visits\n* Subjects with\n\n * Necrotic tissue with eschar present\n * Untreated osteomyelitis\n * Non-enteric and unexplored fistulas\n * Malignancy in wound\n * Exposed vasculature\n * Exposed nerves\n * Exposed anastomotic site of blood vessels or bypasses\n * Exposed organs\n* Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n* Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives'}, 'identificationModule': {'nctId': 'NCT04593693', 'briefTitle': 'A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medela AG'}, 'officialTitle': 'A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types', 'orgStudyIdInfo': {'id': 'GHC1901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Invia Motion Endure NPWT system', 'description': 'Use of Negative Pressure Wound Thearpy', 'interventionNames': ['Device: Invia Motion Endure NPWT system']}], 'interventions': [{'name': 'Invia Motion Endure NPWT system', 'type': 'DEVICE', 'description': 'lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options', 'armGroupLabels': ['Invia Motion Endure NPWT system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Joseph M. Still Burn Center and Wound Clinic at Doctors Hospital', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30106', 'city': 'Austell', 'state': 'Georgia', 'country': 'United States', 'facility': 'JMS Burn Centers, Inc. at Wellstar Cobb Hospital', 'geoPoint': {'lat': 33.81261, 'lon': -84.63438}}], 'overallOfficials': [{'name': 'Claus Brandigi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joseph M. Still Research Foundation, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medela AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Joseph M. Still Research Foundation, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}