Real-Time Accurate Pathology Inspection and Decompression... | NCT05347108

Studies
Real-Time Accurate Pathology Inspection and Decompression Study

NCT05347108

Sponsor

KM Clinical Research Group

Status

Withdrawn

Last Update Posted

Apr 26, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

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

Interventions

laser-assisted neural decompression (LAND) procedure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

May 1, 2022Estimated

Primary Completion Date

Mar 31, 2023Estimated

Completion Date

Jul 31, 2023Estimated

First Submitted Date

Mar 17, 2020

First Submission Date that Met QC Criteria

Apr 20, 2022

First Posted Date

Apr 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2022

Last Update Posted Date

Apr 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Objectives 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.		LAND

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessed with visual analogue scale	Change in pain levels as measured by a visual analogue scale	12-months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KMCRG		Lā‘ie	Hawaii	96762	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease
D059350	Chronic Pain
D001416	Back Pain
D019547	Neck Pain
D011843	Radiculopathy

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations

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Browse Branches

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