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NCT02241954 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
7
Enrollment target

NCT02241954: Completed study, sponsored by Vanderbilt University Medical Center.

NCT02241954 is a clinical trial that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02241954 has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
7 participants
Enrollment target

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

Primary Outcome

1)Record pulmonary function and thoracic volume of TIS patients at enrollment and with serial observation postoperatively (Change from baseline at: 6 week, 12 week, 6 month, and every 6 months after that.)

Interventions

  • DEVICE Synthes VEPTR (Vertical Expandable Prosthetic Titanium Rib)

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2010-11-11
Est. Completion 2020-02-28

What the finished NCT02241954 record still lists

NCT02241954 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 7 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Synthes VEPTR (Vertical Expandable Prosthetic Titanium Rib) is the first listed.

NCT02241954 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02241954 about?

NCT02241954 is a clinical study titled "Vertical Expandable Prosthetic Titanium Rib (VEPTR) for Thoracic Insufficiency Syndrome". 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 expans...

What is the current status of trial NCT02241954?

This trial is currently completed. The enrollment target is 7 participants. The study started on 2010-11-11. Estimated completion is 2020-02-28.

What interventions are being tested in trial NCT02241954?

The interventions under investigation include: Synthes VEPTR (Vertical Expandable Prosthetic Titanium Rib) (DEVICE).

Who is sponsoring clinical trial NCT02241954?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02241954, the US trial registry maintained by the National Library of Medicine. NCT02241954 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.