Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-24 @ 12:26 AM
Study NCT ID:
NCT02598232
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2015-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of the 1,414 nm Nd:YAG Laser System for Alleviating Back Pain in a Lumbar Disc Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Oswestry Disability Index', 'timeFrame': 'Day 0, 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in the Oswestry Disability Index', 'timeFrame': 'Day 0, 4 weeks, 12 weeks'}, {'measure': 'Change in the Visual Analogue Scale', 'timeFrame': 'Day 0, 4 weeks, 12 weeks, 24 weeks'}, {'measure': '12-Item Short-form Health Survey', 'timeFrame': 'Day 0, 4 weeks, 12 weeks, 24 weeks'}, {'measure': "Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria", 'timeFrame': 'Day 0, 4 weeks, 12 weeks, 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lumbar Herniated Intervertebral Disc']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients 19-79 years old\n* Patients with moderate disability based on the Oswestry Disability Index (ODI), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks\n* Patients who have language skills enough to answer questionnaires\n* Patients who agree to voluntarily participate in this study and to sign the Informed Consent Form, and who are able to participate for the entire period of this study\n\nExclusion Criteria:\n\n* Patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc\n* Patients who use an electronic medical device for their cardiovascular system\n* Patients who have spondylolisthesis in the relevant lesion\n* Patients with neurological defects\n* Patients who had undergone surgery on the relevant lumbar vertebra\n* Patients with cauda equina syndrome\n* Patients with congenital spinal deformity\n* Patients with spinal fracture\n* Patients with spinal infection, tumor, or other form of inflammatory spondylopathy\n* Patients with coagulation disorder\n* Patients with a history of malignant tumor (except those with a cured tumor and no re- occurrence for the last five years)\n* Patients who had participated in another clinical study within 30 days from their screening visit\n* Female patients with child-bearing potential who do not agree to use a medically acceptable contraceptive method\\* for up to 24 weeks after the use of the investigational medical device during this study\n\n * Medically acceptable contraceptive method: Condom, oral contraceptive pills taken continuously for more than three months, contraceptive injection or implants, intra- uterine contraceptive device, etc.\n* Patients who are pregnant or breastfeeding\n* Other patients who are considered unfit to participate in this study with clinically significant findings based on the investigator's judgment"}, 'identificationModule': {'nctId': 'NCT02598232', 'briefTitle': 'The Efficacy and Safety of the 1,414 nm Nd:YAG Laser System for Alleviating Back Pain in a Lumbar Disc Patient', 'organization': {'class': 'INDUSTRY', 'fullName': 'LUTRONIC Corporation'}, 'officialTitle': 'A 24-week, Single-center, Open-label, Clinical Study to Evaluate the Efficacy and Safety of the 1,414nm Nd:YAG Laser System Added to PEN to Further Alleviate Back Pain in a Lumbar Herniated Intervertebral Disc Patient', 'orgStudyIdInfo': {'id': 'LU-DL-14-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1,414nm Nd:YAG laser', 'description': 'It has high absorption coefficient in water and a short pulse width.', 'interventionNames': ['Device: 1,414nm Nd:YAG Laser System']}], 'interventions': [{'name': '1,414nm Nd:YAG Laser System', 'type': 'DEVICE', 'description': 'It has high absorption coefficient in water and a short pulse width.', 'armGroupLabels': ['1,414nm Nd:YAG laser']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Keung-nyun Kim, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LUTRONIC Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}