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NCT04505579 · ClinicalTrials.gov registry record

The Tether™ - Vertebral Body Tethering System Post Approval Study

A clinical trial of Scoliosis Idiopathic, sponsored by ZimVie.

Recruiting
Registry status
200
Enrollment target
10
Study locations

NCT04505579 is a study of Scoliosis Idiopathic that is actively recruiting participants, run by ZimVie. The registered enrollment target is 200 participants, below the 264-participant average among 5 other Scoliosis Idiopathic trials with a reported enrollment target (24% lower). The trial reports 10 study locations across 10 states.

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The verdict

NCT04505579, a study of Scoliosis Idiopathic, is actively recruiting participants, sponsored by ZimVie.

RECRUITING
Registry status
200 participants
Enrollment target
10
Study locations

Study Summary

This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) with The Tether.

Conditions Studied

Interventions

  • DEVICE Anterior Vertebral Body Tethering

Study Locations (10)

California

  • Rady Children's Hospital - San Diego

Colorado

  • Children's Hospital Colorado - Aurora

Florida

  • Nemours Children's Health - Jacksonville

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Louisiana

  • Ochsner Health - New Orleans

Minnesota

  • Mayo Clinic - Rochester

Missouri

  • University of Missouri - Columbia - Columbia

New York

  • Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2020-10-29
Est. Completion 2027-12-31

Sponsor

ZimVie

10 total trials

What the Registry Record Tells You About NCT04505579

The ClinicalTrials.gov registry entry for NCT04505579 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 264-participant average among 5 other Scoliosis Idiopathic trials with a reported enrollment target (24% lower). The listed sponsor is ZimVie, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Scoliosis Idiopathic appearing as the primary indexed condition, and to 1 intervention - of which Anterior Vertebral Body Tethering is the first listed.

NCT04505579 reports 10 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT04505579 about?

NCT04505579 is a clinical study titled "The Tether™ - Vertebral Body Tethering System Post Approval Study". This study is an opportunity to provide continued reasonable assurance of the safety and probable benefit of The Tether HUD. The study will collect long term safety and efficacy information from patients who have had their idiopathic scoliosis treated via anterior vertebral body tethering (AVBT) wit...

What is the current status of trial NCT04505579?

This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2020-10-29. Estimated completion is 2027-12-31.

What conditions does trial NCT04505579 study?

This clinical trial studies the following conditions: Scoliosis Idiopathic.

What interventions are being tested in trial NCT04505579?

The interventions under investigation include: Anterior Vertebral Body Tethering (DEVICE).

Who is sponsoring clinical trial NCT04505579?

This trial is sponsored by ZimVie, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04505579 being conducted?

This trial has 10 study locations across California, Colorado, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.