Real-Time Accurate Pathology Inspection and Decompression Study
NCT ID: NCT05347108
Last Updated: 2022-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2022-05-01
2023-07-31
Brief Summary
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Detailed Description
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Design and Outcomes This is a prospective observational study to determine the degree to which a laser-assisted neural decompression (LAND) procedure relieves spine and extremity pain. Subjects will have elected to have the procedure are part of their standard of care in treating their spine and/or leg pain. Subjects will complete a baseline survey and two follow-up surveys at 3-months and 12-months after their procedure date.
Interventions and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre- and post-operative pain, quality of life, satisfaction, and medication use. Subjects will be followed for 12 months following their LAND procedure.
Sample Size and Population This study will last for 4 years starting February 10, 2020. There will be no maximum subject population size. We aim for a minimum population size of 1,500 in order to give statistical significance with results.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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laser-assisted neural decompression (LAND) procedure
The LAND procedure is a minimally invasive spinal decompression procedure that uses a focused laser beam to reduce and remove disc herniations that are causing nerve compressions and impingements within the spinal canal. It is performed in an outpatient setting and the patient receives local anesthesia.
The LAND procedure has been performed extensively over the past 2-years on hundreds of patients, so including patients that have previously had the surgery allows for additional data points and improved reporting.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.
* Willing and able to adhere to the protocol of the study including the survey timeline.
* Between the ages of 18-85 years.
Exclusion Criteria
* Not a candidate for the LAND procedure
18 Years
85 Years
ALL
No
Sponsors
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KM Clinical Research Group
INDUSTRY
Responsible Party
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Locations
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KMCRG
Lā‘ie, Hawaii, United States
Countries
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Other Identifiers
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CMC-01-2020
Identifier Type: -
Identifier Source: org_study_id
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