Lumbar Spinal StenosisPhase 4MiDAS INCT00956631

MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

A Phase 4 study testing Interlaminar Decompression in people with Lumbar Spinal Stenosis, run by Vertos Medical, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lumbar Spinal Stenosis
What is being tested?: Interlaminar Decompression
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 13 sitesUnited States
Study dates: Jul 2008to Apr 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
Prior failure of conservative therapy.
Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5mm, confirmed by pre-op MRI and/or CT.
Central canal cross sectional area ≤ 100 square mm.
Anterior listhesis ≤ 5.0mm.
Able to walk at least 10 feet unaided before being limited by pain.

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Available to complete 12 weeks of follow-up.
Consistent with the intended labeling statement for use.
Able to use all package components to perform the procedure.
A signed Informed Consent Form is obtained from the patient.

Who cannot join

Prior surgery at intended treatment level.
History of recent spinal fractures with concurrent pain symptoms.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
Significant / symptomatic disk protrusion or osteophyte formation.
Excessive / symptomatic facet hypertrophy.
Bleeding disorders and/or current use of anti-coagulants.

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Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
Epidural steroids within prior three weeks.
Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
Any potential wound healing pathologies that may compromise outcomes, including diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
Dementia and/or inability to give informed consent.
Pregnancy.
Intended treatment that is defined by the product labeling contraindications.
On Workman's Compensation or considering litigation associated with back pain.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

The Spine Center
Baltimore, Maryland, 21211
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, 34209
Orthopedic Associates of the Greater Lehigh Valley
Easton, Pennsylvania, 18045
Rainer Vogel, MD LTD
Henderson, Nevada, 89074
NEA Clinic
Jonesboro, Arkansas, 72401
Lab2Marche, LLC
Las Vegas, Nevada, 89149
UCLA
Los Angeles, California, 90095
MedCentral Health System
Mansfield, Ohio, 44903
South Florida Spine Institute
Miami Beach, Florida, 33140
Napa Pain Institute
Napa, California, 94558
Scripps, Division of Orthopedic Surgery
San Diego, California, 92037
UCSD
San Diego, California, 92037
Your Pain Care
Temecula, California, 92591

Other trials in United States

About this study

This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.

Conditions: Lumbar Spinal Stenosis
Being tested: Interlaminar Decompression
Keywords: Spinal Stenosis, Lumbar Spinal Stenosis
Medical subject headings: Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interlaminar DecompressionProcedure or surgery
Also called mild® Device Kit, percutaneous decompression
The MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.

Study groups in NCT00956631
Study group	Role	What they receive
interlaminar decompression	Other	Commercially available product (mild® Device Kit) used to perform interlaminar decompression Receives: Procedure: Interlaminar Decompression

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.
Measured: Baseline and Six Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Apr 2012

First posted11 Aug 2009 (estimated)
Study startJul 2008
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00956631
Sponsor's protocol ID: MiDAS I
Acronym: MiDAS I
Status last verified: Feb 2013
First submitted: 7 Aug 2009
Last updated: 4 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010 Jul-Aug;13(4):369-78.
PubMed 20648206

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis

All Lumbar Spinal Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
ClinicalTrials.gov ID: NCT00956631
Acronym / sponsor ID: MiDAS I / MiDAS I
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis, Lumbar Spinal Stenosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Vertos Medical, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 11 Aug 2009 (estimated)
Results: Posted 4 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
interlaminar decompression	Other	Procedure: Interlaminar DecompressionCommercially available product (mild® Device Kit) used to perform interlaminar decompression

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
Prior failure of conservative therapy.
Radiologic evidence of LSS (L3-L5), Ligamentum flavum > 2.5mm, confirmed by pre-op MRI and/or CT.
Central canal cross sectional area ≤ 100 square mm.
Anterior listhesis ≤ 5.0mm.

Key exclusion criteria (14 listed)

Prior surgery at intended treatment level.
History of recent spinal fractures with concurrent pain symptoms.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
Significant / symptomatic disk protrusion or osteophyte formation.
Excessive / symptomatic facet hypertrophy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interlaminar DecompressionAlso: mild® Device Kit, percutaneous decompressionThe MILD® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompression.	Procedure or surgery	interlaminar decompression

Primary outcome

Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Time frame: Baseline and Six Months
The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.

Results and safety

Results posted to the registry on 4 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mild Procedure	78	62

Primary outcome: Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).

Time frame: Baseline and Six Months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Mild Procedure n = 62
Value	3.21 (p<0.0001)

Mild Procedure: Mean Difference (Final Values): 3.2 (95% CI 2.29 to 4.13), p <0.0001, t-test, 2 sided

Population analysed: All available treated patients at Month 6.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mild Procedure	0 of 78 (0%)	0 of 78 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20648206Chopko B, Caraway DL. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study. Pain Physician. 2010 Jul-Aug;13(4):369-78.

Related trials for Lumbar Spinal Stenosis

Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Caraway, MD principal investigator

The Center for Pain Relief Tri-State, PLLC

Bohdan W Chopko, MD principal investigator

MedCentral Health System

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Interlaminar Decompression in people with Lumbar Spinal Stenosis, run by Vertos Medical, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). (time frame: Baseline and Six Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00956631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.