Minimally Invasive Closure of Umbilical Hernias (MIC)

October 4, 2017 updated by: South Shore Hospital

Study of Minimally Invasive Closure of Umbilical Hernias

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • South Weymouth, Massachusetts, United States, 02190
        • Children's Hospital Boston and South Shore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Deflux
Treatment with Deflux.
Device: Deflux
Patients undergo surgery using Deflux to correct umbilical hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Close Belly Button or Umbilical Hernia
Time Frame: After surgery, subjects will be followed at intervals of one month and six months from date of surgery.
The study was terminated prematurely by the IRB. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.
After surgery, subjects will be followed at intervals of one month and six months from date of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Shore Hospital

Collaborators

Q-Med Scandinavia, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

June 26, 2008

First Posted (ESTIMATE)

June 27, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSH ID 07-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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