Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00951067
Status:
WITHDRAWN
Last Update Posted:
2014-01-31
First Post:
2009-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding not available to continue with study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-30', 'studyFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm Volume', 'timeFrame': 'Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts'}], 'secondaryOutcomes': [{'measure': 'Infection (cellulitis)', 'timeFrame': 'Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts'}, {'measure': 'Quality of Life Survey', 'timeFrame': 'Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphedema', 'Breast Cancer', 'Upper Extremity', 'Arm'], 'conditions': ['Lymphedema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how well different treatments for acquired lymphedema work.\n\nThe study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.', 'detailedDescription': 'This study will compare 5 non-invasive lymphedema treatments.\n\nPatients will be assigned to either:\n\n\\- A combination of arm exercises, arm elevation, and wearing of a compression garment every day\n\nOR\n\n\\- One of four possible pneumatic compression devices for just two hours every day.\n\nPneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.\n\nNone of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.\n\nThe trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with acquired lymphedema of the arm.\n\nExclusion Criteria:\n\n* Refusal of consent\n* Unlikely compliance with the research protocol\n* Acute upper extremity DVT'}, 'identificationModule': {'nctId': 'NCT00951067', 'acronym': 'PCD-LYMPH', 'briefTitle': 'Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema', 'orgStudyIdInfo': {'id': 'AQ-UE-LYMPHEDMA-PCD-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Exercise, Elevation, and Garment Compression', 'interventionNames': ['Other: Exercise, Elevation, and Compression Garment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Pneumatic Compression Device (B)', 'interventionNames': ['Device: E0650 PCD with non-sequential waveform']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Pneumatic Compression Device (C)', 'interventionNames': ['Device: E0651 PCD with sequential, non-gradient waveform']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'Pneumatic Compression Device (D)', 'interventionNames': ['Device: E0652 PCD with sequential, gradient waveform']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group E', 'description': 'Pneumatic Compression Device (E)', 'interventionNames': ['Device: E0652 PCD with peristaltic pulse waveform']}], 'interventions': [{'name': 'Exercise, Elevation, and Compression Garment', 'type': 'OTHER', 'description': 'Patients will be asked to daily:\n\n* exercise\n* elevate arm\n* wear an arm compression garment', 'armGroupLabels': ['Group A']}, {'name': 'E0650 PCD with non-sequential waveform', 'type': 'DEVICE', 'otherNames': ['Brand: Huntleigh Flowtron Hydroven™ 3'], 'description': 'Use of an E0650 PCD with non-sequential waveform for two hours every day.', 'armGroupLabels': ['Group B']}, {'name': 'E0651 PCD with sequential, non-gradient waveform', 'type': 'DEVICE', 'otherNames': ['Brand: Petite Basic System (Model 701A) Lympha Press'], 'description': 'Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day', 'armGroupLabels': ['Group C']}, {'name': 'E0652 PCD with sequential, gradient waveform', 'type': 'DEVICE', 'otherNames': ['Brand: Bio Compression Sequential Circulator 3008'], 'description': 'Use of an E0652 PCD with sequential, gradient waveform for two hours every day.', 'armGroupLabels': ['Group D']}, {'name': 'E0652 PCD with peristaltic pulse waveform', 'type': 'DEVICE', 'otherNames': ['NormaTec brand'], 'description': 'Use the E0652 PCD with peristaltic pulse waveform for two hours every day.', 'armGroupLabels': ['Group E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02453', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston at Waltham", 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'overallOfficials': [{'name': 'Arin K Greene, MD, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'NormaTec Industries LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}