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Minimally Invasive Closure of Umbilical Hernias (MIC)

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ClinicalTrials.gov Identifier: NCT00706329
Recruitment Status : Terminated (The study was terminated prematurely by the IRB due to data integrity and protocol compliance issues)
First Posted : June 27, 2008
Results First Posted : August 28, 2013
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Umbilical Hernia Device: Deflux

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Minimally Invasive Closure of Umbilical Hernias
Study Start Date : April 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Deflux
Treatment with Deflux.
Device: Deflux
Patients undergo surgery using Deflux to correct umbilical hernia


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00706329


Locations
United States, Massachusetts
Children's Hospital Boston and South Shore Hospital
South Weymouth, Massachusetts, United States, 02190
Sponsors and Collaborators
South Shore Hospital
Q-Med Scandinavia, Inc.
Investigators
Principal Investigator: Neil R. Feins, M.D. Children's Hospital Boston and South Shore Hospital
More Information

Responsible Party: South Shore Hospital
ClinicalTrials.gov Identifier: NCT00706329     History of Changes
Obsolete Identifiers: NCT00839618
Other Study ID Numbers: SSH ID 07-003
First Posted: June 27, 2008    Key Record Dates
Results First Posted: August 28, 2013
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by South Shore Hospital:
Minimally invasive surgery
Umbilical hernia
Infant

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal