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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Vertos Medical, Inc.

ClinicalTrials.gov Identifier:

NCT01082159

First received: March 4, 2010

Last updated: February 21, 2013

Last verified: February 2013

History of Changes

Results First Received: February 15, 2013

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lumbar Spinal Stenosis
Intervention:	Procedure: lumbar decompression

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from July 2008 through January 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lumbar Decompression	Single arm cohort having percutaneous decompression using the mild Device Kit

Participant Flow: Overall Study

	Lumbar Decompression
STARTED	55
COMPLETED	46
NOT COMPLETED	9

Baseline Characteristics

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Reporting Groups

	Description
Lumbar Decompression	Single arm cohort having percutaneous decompression using the mild Device Kit

Baseline Measures

	Lumbar Decompression
Number of Participants [units: participants]	55
Age [units: participants]
<=18 years	0
Between 18 and 65 years	21
>=65 years	34
Age [units: years] Mean ± Standard Deviation	68.3 ± 12.1
Gender [units: participants]
Female	32
Male	23
Region of Enrollment [units: participants]
United States	55

Outcome Measures

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1. Primary:

Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). [ Time Frame: Baseline and Month 6 ]

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2. Primary:

Function as Measured Subjectively by the Oswestry Disability Index Questionnaire [ Time Frame: Baseline and Month 6 ]

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3. Primary:

Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS). [ Time Frame: Baseline and Month 6 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: VP Clinical Research
Organization: Vertos Medical
phone: 949-349-0008 ext 216
e-mail: cmyers@vertosmed.com

No publications provided

Responsible Party:	Vertos Medical, Inc.
ClinicalTrials.gov Identifier:	NCT01082159 History of Changes
Other Study ID Numbers:	MiDAS II
Study First Received:	March 4, 2010
Results First Received:	February 15, 2013
Last Updated:	February 21, 2013
Health Authority:	United States: Institutional Review Board

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