Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 7:04 PM
Study NCT ID:
NCT01704157
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2012-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MedInfo@Pacira.com', 'phone': '1-855-793-9729', 'title': 'Pacira MedInfo', 'organization': 'Pacira Bioscience, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from treatment day through Day 140', 'eventGroups': [{'id': 'EG000', 'title': 'Open Treatment', 'description': 'Cryo-Touch III Device', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 9, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Right leg numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea duringprocedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arm Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenderness to palpation in thigh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'clicking sound in knee with standing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tingling/pain in feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Leg numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain/loss of full range of motion with pivot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Improvement in VAS Pain Score From Baseline to Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Treatment', 'description': 'Cryo-Touch III Device'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7', 'description': 'Visual Analog Scale(VAS), where a higher score indicates greater intensity; 0= no pain, 10=worst pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Improvement in WOMAC Index From Baseline to Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Treatment', 'description': 'Cryo-Touch III Device'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'spread': '53.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale.\n\nA tri-dimensional, disease-specific, patient-reported outcome measure. Consists of 24 questions: 5 pain, 2 stiffness and 17 function. Each category contains a set of questions rated by the Subject on a 0-10 scale;\n\nThe highest possible score was 50 for pain, 20 for stiffness and 170 for function, based on the 0-10 scale used to assess each question.\n\nThe total score range is 0 to 240 with higher scores correlating to worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Continued Treatment Effect at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Treatment', 'description': 'Treatment with Cryo-Touch III Device'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Day 30', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)', 'description': 'Subjects were asked to report whether they experienced continued treatment effect at the timepoints indicated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Treatment', 'description': 'Treatment with Cryo-Touch III Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were prospectively enrolled at 2 sites. Enrollment was initiated September 18, 2012 and completed March 25, 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Treatment', 'description': 'Cryo-Touch III Device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Gender', 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average Baseline Pain Score- Visual Analog Scale (VAS)', 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '1.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Visual Analog Scale, 0-10 where a higher score indicates greater intensity', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average Baseline Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale', 'classes': [{'categories': [{'measurements': [{'value': '125.8', 'spread': '42.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale.\n\nA tri-dimensional, disease-specific, patient-reported outcome measure. Consists of 24 questions: 5 pain, 2 stiffness and 17 function. Each category contains a set of questions rated by the Subject on a 0-10 scale;\n\nThe highest possible score was 50 for pain, 20 for stiffness and 170 for function, based on the 0-10 scale used to assess each question.\n\nThe total score range is 0 to 240 with higher scores correlating to worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-06-25', 'size': 381472, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-02T15:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2012-10-05', 'resultsFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2012-10-09', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-06', 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Improvement in VAS Pain Score From Baseline to Day 7', 'timeFrame': 'Baseline to Day 7', 'description': 'Visual Analog Scale(VAS), where a higher score indicates greater intensity; 0= no pain, 10=worst pain'}, {'measure': 'Improvement in WOMAC Index From Baseline to Day 7', 'timeFrame': 'Baseline to Day 7', 'description': 'The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale.\n\nA tri-dimensional, disease-specific, patient-reported outcome measure. Consists of 24 questions: 5 pain, 2 stiffness and 17 function. Each category contains a set of questions rated by the Subject on a 0-10 scale;\n\nThe highest possible score was 50 for pain, 20 for stiffness and 170 for function, based on the 0-10 scale used to assess each question.\n\nThe total score range is 0 to 240 with higher scores correlating to worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced Continued Treatment Effect at Each Time Point', 'timeFrame': 'Visit 3 (Day 7), Visit 4 (Day 30), Visit 5 (Day 56)', 'description': 'Subjects were asked to report whether they experienced continued treatment effect at the timepoints indicated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'knee', 'chronic pain'], 'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'A proof of concept study to evaluate the feasibility of safe and effective treatment through optimization of the Cryo-Touch III device for temporary relief of pain.', 'detailedDescription': "Over 100 million patients in the United States suffer from chronic pain. Chronic pain conditions are often debilitating, taking a toll on a patient's physical and mental welfare. Though a variety of pain management techniques currently exist, the most common nonsurgical options provide slow-acting and/or short-term relief. Medication, often in the form of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, comes with an array of side effects such as nausea and vomiting. Medication also presents the possibility of more serious effects such as increased risk of heart attack and stroke, and tolerance or dependency issues. Surgical strategies tend to be reserved for more severe cases and are limited by the risks and complications typically associated with surgery including bleeding, bruising, scarring, and infection. A nonsurgical, minimally invasive, long-lasting approach to chronic pain management is desirable.\n\nThe Cryo-Touch III is a pain management device developed for a novel, minimally invasive procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting pain relief through cryoanalgesia. The device operates on the well-established cryobiology principle that localized exposure to controlled moderately low temperature conditions can alter tissue function. The therapy treats nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling.\n\nThough studies have proven efficacious in targeting motor nerves, the device's effect on sensory nerves has yet to have been investigated in the clinical setting. The goal of the study described herein is to evaluate the degree and duration of effect of the Cryo-Touch III in reducing chronic pain by targeting sensory nerves."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18 years of age and older.\n* Participants must meet American College of Rheumatology (ACR) criteria for osteoarthritis of the knee (unilateral or bilateral). Clinical criteria includes knee pain and at least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, and/or no warmth to the touch.\n* Any medications (prescription and/or over-the counter) must be maintained on a stable schedule for ≥ 2 weeks prior to treatment. No washout period is allowed.\n* An average Visual Analog Scale (VAS) for pain ≥ 4 over the last 30 days.\n* Subject is willing and able to give written informed consent.\n* Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.\n* Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.\n\nExclusion Criteria:\n\n* A partial or full knee replacement (in the treated knee).\n* Any use of systemic injections (in any area) within the last 6 months.\n* Current enrollment in an investigational drug or a device study that specifically targets pain treatment.\n* Any additional diagnosis that in the opinion of the investigator may directly contribute to knee pain.\n* Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bones disease, gout, active infection, etc.).\n* Any clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device.\n* Allergy or intolerance to lidocaine.\n* Any local skin condition at the treatment site that in the investigator's opinion would adversely affect treatment or outcomes.\n* Any chronic medical condition that in the investigator's opinion would prevent adequate participation.\n* Any chronic medication use (prescription, over-the-counter, etc.) that in the investigator's opinion would affect study participation or subject safety.\n* For any reason, in the opinion of the investigator, the subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related knee injury due to a worker's compensation claim, etc.)."}, 'identificationModule': {'nctId': 'NCT01704157', 'briefTitle': 'A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pacira Pharmaceuticals, Inc'}, 'officialTitle': 'A Prospective Non-Randomized Unblinded Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device', 'orgStudyIdInfo': {'id': 'MYO-0601'}, 'secondaryIdInfos': [{'id': 'Pain-OA', 'type': 'OTHER', 'domain': 'MyoScience'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open Treatment', 'description': 'Treatment with Cryo-Touch III Device', 'interventionNames': ['Device: Cryo-Touch III']}], 'interventions': [{'name': 'Cryo-Touch III', 'type': 'DEVICE', 'description': 'Study treatment at Day 0.', 'armGroupLabels': ['Open Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94557', 'city': 'Napa', 'state': 'California', 'country': 'United States', 'facility': 'Neurovations', 'geoPoint': {'lat': 38.29714, 'lon': -122.28553}}, {'zip': '83713', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Injury Care Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}