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Minimally Invasive Closure of Umbilical Hernias

NCT ID: NCT00706329

Last Updated: 2017-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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All patients will undergo general anesthesia for their primary procedure, i.e. inguinal hernia repair. Once under general anesthesia, the abdomen will be prepped and draped in the usual sterile surgical fashion. The edge of the umbilical hernia defect will be palpated and in case there are any contents of the hernia present, they will be pushed into the abdominal cavity. Adequate relaxation, again, will be assured. A 24 gauge needle will be used to inject 1cc of Deflux ("Study Product") into each quadrant at the junction between the preperitoneal space and the inner palpable rim of the fascial defect. The surgeon's index finger stays in the center of the hernia defect, protecting the hernia sac contents from re-herniating. Closure of the umbilical defect will be confirmed by palpation immediately after injection. A sterile wound dressing will be applied and the primary surgical procedure will be performed afterwards.

Definition of Primary and Secondary Outcomes/Endpoints:

The endpoint of this study is closure of the umbilical hernia.

Data Collection Methods, Assessments, and Schedule (what assessments performed, how often): A data collection file is started at the time of enrollment in the study. Data collection includes patient age, gender, and weight at the time of operation, inner diameter of the umbilical hernia defect at the time of operation, description of the immediate postoperative results and follow-up exams at two weeks, one month, and six months.

Conditions

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Umbilical Hernia

Keywords

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Minimally invasive surgery Umbilical hernia Infant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deflux

Treatment with Deflux.

Group Type EXPERIMENTAL

Deflux

Intervention Type DEVICE

Patients undergo surgery using Deflux to correct umbilical hernia

Interventions

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Deflux

Patients undergo surgery using Deflux to correct umbilical hernia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 1-5 years
* Umbilical hernia\>1cm. diameter.
* Undergoing either a general surgical or urologic procedure under general anesthesia other than umbilical hernia repair.
* No previous umbilical hernia repair.

Exclusion Criteria

* Over 5 years
* No umbilical hernia
* No other surgery required
* Previous umbilical hernia repair
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Q-Med Scandinavia, Inc.

INDUSTRY

Sponsor Role collaborator

South Shore Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil R. Feins, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Boston and South Shore Hospital

Locations

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Children's Hospital Boston and South Shore Hospital

South Weymouth, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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SSH ID 07-003

Identifier Type: -

Identifier Source: org_study_id

NCT00839618

Identifier Type: -

Identifier Source: nct_alias