PMCFU of an Annular Closure System

Study Purpose

The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.

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
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Records for any subject treated with a Barricaid annular closure device will be considered for inclusion into the study.

Exclusion Criteria:

- Records for any subject treated without a Barricaid annular closure device will be considered for exclusion

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.

NCT05467072
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.

Intrinsic Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David H Kim, MD
Principal Investigator Affiliation New England Baptist Hospital
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 Disc Herniation
Additional Details

Retrospective chart review of patients treated with lumbar discectomy and annular closure. Review of patient charts through 3 month post op, for analysis of symptomatic lumbar reherniation at the index level.

Arms & Interventions

Arms

: Discectomy + annular closure

All patients treated with lumbar discectomy and implantation of an annular closure device

Interventions

Device: - Annular closure

Lumbar discectomy patients treated with Annular Closure Device BARRICAID

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.

Orthopedic Institute of Western Kentucy, Paducah, Kentucky

Status

Recruiting

Address

Orthopedic Institute of Western Kentucy

Paducah, Kentucky, 42001

Site Contact

Rebekah Vinson

[email protected]

270-442-9461