PMCFU of an Annular Closure System | NCT05467072

Studies
PMCFU of an Annular Closure System

NCT05467072

Sponsor

Intrinsic Therapeutics

Status

Unknown status

Last Update Posted

Sep 29, 2023Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Lumbar Disc Herniation

Interventions

Annular closure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 27, 2023Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

Jul 18, 2022

First Submission Date that Met QC Criteria

Jul 18, 2022

First Posted Date

Jul 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2023

Last Update Posted Date

Sep 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Discectomy + annular closure		All patients treated with lumbar discectomy and implantation of an annular closure device	Device: Annular closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Annular closure	Device	Lumbar discectomy patients treated with Annular Closure Device BARRICAID	Discectomy + annular closure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptomatic reherniation	Reherniation of the index lumbar disc level, with patient symptoms (back or leg pain)	3 months post op

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient previously treated with lumbar discectomy and annular closure, with 3 month post op follow up data available

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kelsey A Miller-Torchia, BA	Contact	7819320222	132	kmiller@in-thera.com
Ivan Grzan, BS	Contact	7819320222		ivan@in-thera.com

Overall Officials

Name	Affiliation	Role
David H Kim, MD	New England Baptist Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopedic Institute of Western Kentucy	Recruiting	Paducah	Kentucky	42001	United States

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided