Rampart Duo Clinical (RaDical) Post-Market Study

Study Purpose

This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation will be conducted at up to a maximum of 20 investigation centers with no more than 200 study subjects being enrolled. Data is being collected for patients undergoing a standard of care, on-label, lateral lumbar interbody fusion. The data collected in this evaluation will be used for publication and presentation.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	21 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- A clinical decision has been made to treat the patient with the Rampart Duo Interbody Spacer prior to enrollment into this research evaluation.

This decision is independent (made outside) of the decision to take part in the research.

Exclusion Criteria:

- Previous interbody fusion or total disc replacement at the index level(s).

- Enrolled in a concurrent clinical investigation that may confound the findings of the present investigation.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03974711
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Spineology, Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Donald Erickson, M.D.
Principal Investigator Affiliation	Independent
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lumbar Degenerative Disc Disease

Additional Details

The purpose of this study is to collect data that reports on the clinical outcomes of patients treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels. Data is collected prospectively at specified time points per protocol and includes both objective and subjective measures. Patients will be followed to a maximum of two years.

Arms & Interventions

Arms

: All study subjects

Note: No interventions are administered under this evaluation. This is a real-world population. The determination to undergo a lateral lumbar interbody fusion procedure is made outside of this evaluation and is a standard of care, on-label procedure.

Interventions

Other: - In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.

There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fremont, California

Status

Recruiting

Address

Bell Neuroscience Institute/Washington Township Medical Foundation

Fremont, California, 94538

Site Contact

Kristi LaRock, PA

[email protected]

510-818-1160

Loma Linda University, Loma Linda, California

Status