Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT02366832
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation for Phantom Limb Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully', 'timeFrame': 'Post-Cryoablation', 'description': 'Feasibility, defined by number of participants, in which cryoablation was performed successfully'}, {'measure': 'Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs).', 'timeFrame': '56 days', 'description': 'Safety is measured by the number of subjects that had cryoablation procedure events (CPEs). CPEs are device- or procedure-related serious adverse events (SAE) or adverse events (AE) categorized as clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), nerve pain worsening, or toxicity of any kind (confusion, seizure).'}], 'secondaryOutcomes': [{'measure': 'Change in pain scores on visual analogue scale (VAS )', 'timeFrame': 'Baseline, day 56', 'description': "Change in pain score will be calculated by subtracting the day 56 pain score from the baseline pain score.The pain scores are on a continuous visual analogue scale of 0 to 100 mm. 0 mm = no pain and 100 mm = worst possible pain. The VAS is scored simply by measuring the distance, in mm, from the patient's mark to one of the ends of the line."}, {'measure': 'Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ)', 'timeFrame': 'Baseline, day 56', 'description': 'Quality of life will be measured using Roland-Morris Disability Questionnaire (RDQ); it is a validated measure of physical disability due to low back pain.The best score is 0 (no disability) and worst is 24 (maximum disability).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Phantom Limb Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://youtu.be/ORQKe7tTyFo', 'label': 'YouTube Video'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if treatment with percutaneous cryoablation yields significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).', 'detailedDescription': 'This study aims to treat Phantom Limb Syndrome (PLS) with cryoablation of the remaining nerve stumps. The rationale is that because the pain in PLS follows the known distribution of nerves, and because the amputated nerves are known to undergo changes after the surgery that may lead to excessive "firing," that interruption of the nerve impulses will reduce patient pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are status post (s/p) amputation of an upper or lower limb. That is, the amputation is not congenital.\n* Refractory pain symptoms, following tissue healing(postoperatively, or post injury) are related to amputation as determined by referring physician and investigator, to include: stump pain, phantom pain, unpleasant phantom sensations, and/or undesirable and/or life-limiting kinesthetic sensations. The character, frequency, location, description, and exacerbation or relieving elements will be recorded.\n\nPatients will be questioned as to the location of their sensation, be it pain, movement, burning, tingling, or other. The location of their pain will be correlated with the corresponding proximal nerve stump.\n\n* Positive anesthetic/steroid block, as performed under CT guidance in an analogous fashion to the cryoablation procedure.\n* Absence of infection\n* Absence of coagulopathy\n* Ability and willingness of patient to provide written informed consent\n\nExclusion Criteria:\n\n* Active infection\n* Underlying congenital segmentation or other spinal anomalies that result in differential nerve root pressures\n* Significant spinal stenosis interpreted as "severe" on any cross sectional imaging study\n* Pregnant or planning to become pregnant\n* Immunosuppression\n* History or laboratory results indicative of any significant cardiac, endocrine, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neoplastic, or other disorder that in the opinion of the Principal Investigator would preclude the safe performance of cryoablation.\n* Uncorrectable coagulopathies\n* Concurrent participation in another investigational trial involving systemic administration of agents or within the previous 30 days.\n* Have undergone a previous surgical intervention - post amputation - that may have altered the target nerve.'}, 'identificationModule': {'nctId': 'NCT02366832', 'briefTitle': 'Cryoablation for Phantom Limb Pain', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Percutaneous Image Guided Cryoablation for the Treatment of Refractory Phantom Limb Pain', 'orgStudyIdInfo': {'id': 'IRB00078008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryoablation', 'description': 'Amputee subjects experiencing phantom limb syndrome (PLS) will receive cryoablation', 'interventionNames': ['Procedure: Cryoablation', 'Device: 17g Galil Medical Ice Sphere cryoablation needle']}], 'interventions': [{'name': 'Cryoablation', 'type': 'PROCEDURE', 'otherNames': ['Cryotherapy', 'Cryosurgery'], 'description': 'Subjects who respond to lidocaine nerve block will undergo CT guided cryoablation of the affected nerve stump with a 17g Galil Medical Ice Sphere cryoablation needle.', 'armGroupLabels': ['Cryoablation']}, {'name': '17g Galil Medical Ice Sphere cryoablation needle', 'type': 'DEVICE', 'description': 'Under CT guidance, the corresponding nerve will be targeted with a 17g probe. Two freeze-thaw cycles will be undertaken. The probe will be removed and a final scan obtained.', 'armGroupLabels': ['Cryoablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'John D Prologo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'John Prologo', 'investigatorAffiliation': 'Emory University'}}}}