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Study of Lumbar Discectomy With Annular Closure

NCT03986580 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-09-28

No results posted yet for this study

Summary

The purpose of this prospective, single-arm, multicenter study is to assess an annular closure device when used as an adjunct to a primary lumbar limited discectomy, to limited discectomy alone.

Conditions

  • Lumbar Disc Herniation

Interventions

DEVICE

Annular closure device

Annular closure, following limited discectomy procedure at a single LS level between L4 and S1

Sponsors & Collaborators

  • Intrinsic Therapeutics

    lead INDUSTRY

Principal Investigators

  • David H Kim, MD · New England Baptist Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2024-06-30
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986580 on ClinicalTrials.gov