The Ailliance Post-Market Clinical Study

a study on Spinal Deformity Spinal Degenerative Disorder Spinal Fusion Failure Spinal Trauma Spinal Tumor Case

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Aaron Clark, MD
Headshot of Aaron Clark
Aaron Clark

Description

Summary

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s).

Subjects are enrolled and followed postoperatively for up to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

Official Title

The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction

Keywords

Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor Case, Spinal Cord Neoplasms, Spinal Neoplasms, Follow-up schedule: pre-operative baseline to index surgery, Follow-up schedule: pre-operative baseline to discharge, Follow-up schedule: pre-operative baseline up to 24-months post-procedure

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject provides written informed consent per institution and/or geographical requirements.
  2. Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
  3. Subject is at least 18 years of age or minimum legal age as required by local regulations.
  4. Subject agrees to complete all required assessments per the Schedule of Events.

You CAN'T join if...

  1. Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
  2. Subject who is, or is expected to be, inaccessible for all required follow-up visits.
  3. Subject with exclusion criteria required by local law.
  4. Subject is considered vulnerable at the time of obtaining consent.

Locations

  • UCSF (UCSF) accepting new patients
    San Francisco California 94143 United States
  • American Neurospine Institute, PLLC accepting new patients
    Frisco Texas 75033 United States

Lead Scientist at UCSF

  • Aaron Clark, MD
    Dr. Aaron Clark is a neurosurgeon specializing in minimally invasive outpatient procedures for lumbar and cervical herniated discs and stenosis, as well as minimally invasive lumbar fusion surgery. These procedures are associated with shorter recovery times and less postoperative pain than standard surgeries, and almost all patients can return home the same day.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Spinal and Biologics
ID
NCT05856370
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated
Contact us about this trial