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PMCFU of an Annular Closure System

Post-Marketing Clinical Follow-up of an Annular Closure System

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05467072
Enrollment
250
Registered
2022-07-20
Start date
2023-09-27
Completion date
2025-10-31
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation

Brief summary

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.

Detailed description

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.

Interventions

DEVICEAnnular closure

Lumbar discectomy patients treated with Annular Closure Device BARRICAID

Sponsors

Intrinsic Therapeutics
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Symptomatic reherniation3 months post opReherniation of the index lumbar disc level, with patient symptoms (back or leg pain)

Countries

United States

Contacts

Primary ContactKelsey A Miller-Torchia, BA
kmiller@in-thera.com7819320222
Backup ContactIvan Grzan, BS
ivan@in-thera.com7819320222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026