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Vertical Expandable Prosthetic Titanium Rib (VEPTR) for Thoracic Insufficiency Syndrome

NCT02241954 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2020-05-12

No results posted yet for this study

Summary

The hypothesis of the study is that individuals with poor pulmonary function secondary to TIS will benefit from expansion thoracoplasty. The investigators specific aims are to:

1. Record pulmonary function and thoracic volume of TIS patients at enrollment and with serial observation
2. Offer expansion thoracoplasty therapy to TIS patients with

1. poor pulmonary function at enrollment
2. progressive decline in pulmonary function
3. progressive chest wall and/or spinal deformity
4. lack of appropriate increase in thoracic volume during growth
3. Document efficacy of expansion thoracoplasty for TIS patients

Conditions

  • Thoracic Insufficiency Syndrome (TIS)

Interventions

DEVICE

Synthes VEPTR (Vertical Expandable Prosthetic Titanium Rib)

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Martus, MD · Vanderbilt University Medical Center

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-11
Primary Completion
2018-03-25
Completion
2020-02-28

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 NCT02241954 on ClinicalTrials.gov