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Minimally Invasive Closure of Umbilical Hernias

NCT00706329 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-11-06

Study results available
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Summary

The purpose of the study is to test the use of "Deflux" injections in a minimally invasive closure of umbilical (belly button) hernias in infants between birth and five years. The study is designed to demonstrate that the use of this device can safely and effectively close an umbilical hernia.

Conditions

  • Umbilical Hernia

Interventions

DEVICE

Deflux

Patients undergo surgery using Deflux to correct umbilical hernia

Sponsors & Collaborators

  • Q-Med Scandinavia, Inc.

    collaborator INDUSTRY

  • South Shore Hospital

    lead OTHER

Principal Investigators

  • Neil R. Feins, M.D. · Children's Hospital Boston and South Shore Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-03-31
Completion
2009-03-31

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 NCT00706329 on ClinicalTrials.gov