Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-02-10 @ 12:32 PM
Study NCT ID:
NCT04109703
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2019-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Chuck@Soovu.com', 'phone': '206-579-4910', 'title': 'Charles Chabal, MD', 'organization': 'Soovu Labs'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months including duration of study until mid November 2019', 'eventGroups': [{'id': 'EG000', 'title': 'High Level Pulsed Heat', 'description': 'Subjects in this group received the active (experimental) device that utilized high level pulsed heat to a temperature of 45 degrees C.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Level Steady Heat Group', 'description': 'Subjects in this group received the control device that utilized steady heat at a temperature of 37 degrees C.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Level Pulsed Heat', 'description': 'Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.\n\nGeneration 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection.'}, {'id': 'OG001', 'title': 'Low Level Steady Heat', 'description': 'Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.\n\nGeneration 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.40', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Demographic and clinical characteristics were tabulated by randomization group. The primary outcome was change in pain score from baseline to 30 minutes after treatment ended. Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level. Unadjusted comparisons are also presented. Change in pain scores at each other post baseline time point were similarly analyzed.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level.', 'nonInferiorityComment': 'The hypothesis is that the high level pulsed heat group will show statistically more pain relief than the low level steady heat group.'}], 'paramType': 'MEAN', 'timeFrame': 'Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.', 'description': 'Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.', 'unitOfMeasure': 'reduction in pain score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pain Relief 30 Minutes After the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Level Pulsed Heat', 'description': 'Subjects who received the high level pulsed heat device with heat pulses up to 45 degrees C.'}, {'id': 'OG001', 'title': 'Steady Heat Group', 'description': 'Subjects who received the steady heat device with heat received a steady level of heat at 37 degrees C.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.40', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes in the Numerical Pain Scale will be compared between baseline and thirty minutes post intervention.', 'description': 'Numerical Pain Scale Range Zero (minimum) through ten (maximum score) In this study a lower number on the Numeric Pain Scale means the subject(s) has less pain. Less pain particularly in the experimental group is a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with longstanding chronic low back pain median duration 10 years. Subjects who received the high level pulsed heat device with heat pulses up to 45 degrees C. Steady heat subjects received a device that heated to 37 degrees C at a steady level.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Level Pulsed Heat', 'description': 'Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.\n\nGeneration 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. The treatment algorithm used for all subjects in this arm pulsed heat to a temperature of 45 degrees C.'}, {'id': 'FG001', 'title': 'Low Level Steady Heat', 'description': 'Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.\n\nGeneration 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. The treatment algorithm used for all subjects in this arm maintained a steady temperature of 37 degrees C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Level Pulsed Heat', 'description': 'Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.\n\nGeneration 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection.'}, {'id': 'BG001', 'title': 'Low Level Steady Heat', 'description': 'Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.\n\nGeneration 5 device Soovu Labs Inc.: The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Starting Numerical Pain Score (NPS 0-10)', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Numerical Pain Scale (NPS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '0.06', 'groupId': 'BG000'}, {'value': '5.55', 'spread': '0.07', 'groupId': 'BG001'}, {'value': '5.55', 'spread': '0.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Numeric Pain Scale is a 0-10 scale. It is validated over multiple populations and is a research standard for assessing pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-03', 'size': 307937, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-05T13:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blinded with a control condition using a low level heating (37 degree C) device. The active experimental device used heast that intermittently pulsed to 45 degrees C.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded, randomized, active placebo controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2019-09-26', 'resultsFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-06', 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain Relief 30 Minutes After the Intervention', 'timeFrame': 'Changes in the Numerical Pain Scale will be compared between baseline and thirty minutes post intervention.', 'description': 'Numerical Pain Scale Range Zero (minimum) through ten (maximum score) In this study a lower number on the Numeric Pain Scale means the subject(s) has less pain. Less pain particularly in the experimental group is a better outcome.'}], 'primaryOutcomes': [{'measure': 'Pain Rating', 'timeFrame': 'Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.', 'description': 'Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'low back pain', 'heat', 'thermal', 'analgesia'], 'conditions': ['Chronic Pain', 'Low Back Pain', 'Heat', 'Analgesia']}, 'descriptionModule': {'briefSummary': 'This study is a double blinded randomized active placebo controlled trial in subjects with chronic low back pain. The trial compares pain relief by a device that delivered high level pulsed heat (45 °C) to pain relief delivered by a steady heat lower temperature device (37 °C). The hypothesis is that the high temperature pulsed heat device will produce significantly better pain relief as compared to the lower level steady heat device. The secondary hypothesis is that pain relief will occur faster in the high pulsed heat device as compared to the control device.', 'detailedDescription': '1. This study will be conducted under Good Clinical Practice (GCP) guidelines and suitable for FDA submission in order to obtain claims such as, "provides temporary pain relief for people with chronic lower back pain."\n2. The study is designed as a randomized double blinded two arm placebo controlled trial.\n3. The active arm (N=50) receives two active Series 5 heating units (Soovu Labs Inc.) that pulse heat to 45ºC (113ºF). The active Series 5 placebo arm (N=50) gets two identical appearing units (Soovu Labs Inc.) that produce low level of heat at 37ºC (96.8 ºF). For reference skin temperature is about 33 ºC and room temperature 23 ºC.\n4. The study hypothesis is that in subjects with chronic low back pain, the active heating device group will show a statistical improvement in pain scores as compared to the active placebo group as measured by the primary outcome measure, the Numeric Pain Scale (NPS).\n5. Subjects will be told the study is examining the pain relieving effectiveness of two different levels of heat.\n6. Subjects must have chronic low back pain with a pretreatment level of pain 4 or greater on a 0-10 point scale. By definition chronic low back pain is a condition that has been present for at least 6 months and must be present more days than not over the course of a week.\n7. No use of pain medications during the four hour trial. However, pain medications including schedule IIIs can be taken up to 30 minutes before the start of the trial. Medications permitted during the trial include medications such as tramadol, codeine, NSIADs, gabapentin and acetaminophen. Non-pain medications for medical indications are permitted at any time. Subjects taking schedule II opioids are excluded from the study. Schedule II opioids include oxycodone, hydromorphone, hydrocodone, fentanyl and methadone.\n8. Ages 22 through 70 inclusive.\n9. Exclusion criteria- sciatica if present must be rated significantly less than the non -radiating component of the low back pain, pregnancy, skin lesions such as open skin or sores, scar tissue, skins grafts, old burns over the treatment area or neuropathic sensory loss over the treatment site.\n10. Pre-treatment assessments include, Numeric Pain Scale, and a pre-study questionnaire (history, treatment preferences, short form Brief Pain Inventory, and short form Magill).\n11. Each treatment session lasts approximately 30 minutes with pain assessments throughout using NPS (primary outcome measure). Secondary outcome measures include measures of comfort and willingness to endorse their treatment.\n12. All subjects are followed for a 4 hour post treatment period with intermittent pain assessments (NPS).\n13. At the end of the post treatment period, subjects complete a post study usability questionnaire and a blinding questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'genderBased': True, 'genderDescription': 'any gender eligible', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chronic low back pain. By definition chronic low back pain is a condition that has been present for at least 6 months on more days than not. If there is a radiating component of the low back pain the radiating component must have a pain rating less than the non-radiating component of the low back pain.\n2. Subjects must have pretreatment level of pain 4 or greater.\n3. Ages 22 through 70 inclusive\n4. Non pain medications are permitted as needed for conditions such as hypertension, diabetes, heart disease etc.\n5. Medications such as tramadol, codeine, NSIADs, gabapentin and acetaminophen are not permitted during the trial but may be included under the discretion of the study physician.\n6. Subjects must have a reliable method for clinic contact and follow-up.\n\n \\-\n\nExclusion Criteria:\n\n1. Sciatica or radicular pain without non-radiating low back pain, cancer, radicular pain greater than the non-radiating component of low back pain, pregnancy, skin lesions such as open skin or sores, scar tissue, skins grafts, old burns over the treatment area.\n2. Medications including oxycodone, hydromorphone, hydrocodone, fentanyl and methadone are excluded from the trial but may be included under the discretion of the study physician. Such decisions will be documented should they occur.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT04109703', 'briefTitle': 'High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soovu Labs Inc.'}, 'officialTitle': 'High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '201969K'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High level pulsed heat', 'description': 'Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.', 'interventionNames': ['Device: High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low level steady heat', 'description': 'Subjects randomized to this arm received an identical generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered in a steady manner at 37° C.', 'interventionNames': ['Device: Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.']}], 'interventions': [{'name': 'High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.', 'type': 'DEVICE', 'otherNames': ['Experimental arm'], 'description': 'The Soovu Labss Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. For this study the treatment algorithm used for subjects in this arm (experimental) used a temperature that was ramped from skin temperature to a peak temperature of 45° C and cycled for 30 minutes.', 'armGroupLabels': ['High level pulsed heat']}, {'name': 'Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.', 'type': 'DEVICE', 'otherNames': ['Control arm'], 'description': 'The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are via a phone-based bluetooth connection. For this control arm of the study the treatment algorithm held a steady temperature of 37 degrees C for a 30 minute period.', 'armGroupLabels': ['Low level steady heat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Research Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'charles chabal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soovu Labs Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soovu Labs Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Northern California Research Corporation', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}