Real-Time Accurate Pathology Inspection and Decompression Study

NCT05347108 | Withdrawn DMC

• 1 other identifier: CMC-01-2020
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (LAND) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain. Secondary objectives will be changes in quality of life, prescription pain medication use, and patient satisfaction with procedure outcomes.

Conditions

Spine Injuries and Disorders; Pain, Chronic; Pain, Back; Pain, Neck; Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Pain assessed with visual analogue scale

  Change in pain levels as measured by a visual analogue scale

  12-months

Interventions

laser-assisted neural decompression (LAND) procedure 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.

Also known as: LAND

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a history of chronic spine and/or extremity pain that have tried at least 6 weeks of conservative care.

You may qualify if:

• Prescribed spinal decompression procedure by their healthcare provider.
• 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.

You may not qualify if:

• Inability or unwillingness to give written informed consent.
• Not a candidate for the LAND procedure

Sponsors & Collaborators

• KM Clinical Research Group: lead

Study Sites (1)

KMCRG

Lā‘ie, Hawaii, 96762, United States

Location

MeSH Terms

Conditions

Disease; Chronic Pain; Back Pain; Neck Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: April 26, 2022
• Study Start: May 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)