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Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis

NCT01465295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-02-05

No results posted yet for this study

Summary

The purpose of this clinical trial is to study a new method of treatment for patients who are diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine. The treatment consists of the surgical implantation of a new medical device called the "HemiBridge™ Clip". This medical implant device has never been used in humans. SpineForm, LLC, the developer of the HemiBridgeTM System has designed this scientific clinical trial, to evaluate the safety of the use of this device in humans. Information collected from patients treated with this new device shall be used to determine the initial safety of the new device.

The FDA has approved the use of the HemibridgeTM System for this research study in 6 (six) pediatric patients who have idiopathic scoliosis.

This procedure is intended to stop additional curvature of the spine by redirecting growth of the bones of the spine (vertebrae). To accomplish this, the patient undergoes a surgical procedure to securely attach small metal clips (HemiBridge™ Clips) to the outer side of each vertebra involved in the curvature. The HemiBridge™ Clip forms a "bridge" between each vertebra and is intended to hold the vertebrae in place to prevent the spine from curving any further.

Conditions

  • Scoliosis

Interventions

DEVICE

Mechanical hemiepiphysiodesis using the HemiBridge System

Surgical application of mechanical hemiepiphysiodesis using the HemiBridge device.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • SpineForm LLC

    lead INDUSTRY

Principal Investigators

  • Joseph E Reynolds, MBA · SpineForm LLC

  • Eric J Wall, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2017-12-29
Completion
2017-12-29

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 NCT01465295 on ClinicalTrials.gov