MILD Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

  • STATUS
    Recruiting
  • End date
    Dec 15, 2024
  • participants needed
    4000
  • sponsor
    Vertos Medical, Inc.
Send
Updated on 15 January 2021
See if I qualify
Investigator
Angie Lee
Primary Contact
Bass Surgery Center (2.2 mi away) Contact
+723 other location

Summary

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

Description

In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46).

Details
Treatment MILD
Clinical Study IdentifierNCT03072927
SponsorVertos Medical, Inc.
Last Modified on15 January 2021

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

 Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have any of these conditions: Do you have Lumbar Spinal Stenosis??
Do you have Lumbar Spinal Stenosis?
Gender: Male or Female
Medicare beneficiaries receiving MILD or interspinous process decompression
Diagnosis of LSS with NC

Exclusion Criteria

Patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or MILD in the lumbar region during the 12 months prior to the index date
Clear my responses
Read more

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name
Edit Delete

Annotated by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet