Minimally Invasive Closure of Umbilical Hernias (MIC)

This study has been terminated.
(The study was terminated prematurely by the IRB due to data integrity and protocol compliance issues)
Sponsor:
Collaborator:
Q-Med Scandinavia, Inc.
Information provided by (Responsible Party):
South Shore Hospital
ClinicalTrials.gov Identifier:
NCT00706329
First received: June 25, 2008
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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 Intervention
Umbilical Hernia
Device: Deflux

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Minimally Invasive Closure of Umbilical Hernias

Resource links provided by NLM:


Further study details as provided by South Shore Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • At Follow up if the Hernia Has Not Closed, Another Surgery May be Required to Close the Umbilical Hernia. [ Time Frame: Seven or more months after initial surgery. ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deflux
Treatment with Deflux.
Device: Deflux
Patients undergo surgery using Deflux to correct umbilical hernia
Other Name: 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.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: South Shore Hospital
ClinicalTrials.gov Identifier: NCT00706329     History of Changes
Obsolete Identifiers: NCT00839618
Other Study ID Numbers: SSH ID 07-003
Study First Received: June 25, 2008
Results First Received: June 5, 2013
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014