Study Stopped
The study was terminated prematurely by the IRB due to data integrity and protocol compliance issues
Minimally Invasive Closure of Umbilical Hernias
MIC
Study of Minimally Invasive Closure of Umbilical Hernias
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 25, 2008
CompletedFirst Posted
Study publicly available on registry
June 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
August 28, 2013
CompletedNovember 6, 2017
October 1, 2017
11 months
June 25, 2008
June 5, 2013
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Close Belly Button or Umbilical Hernia
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.
Study Arms (1)
Deflux
EXPERIMENTALTreatment with Deflux.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Over 5 years
- No umbilical hernia
- No other surgery required
- Previous umbilical hernia repair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South Shore Hospitallead
- Q-Med Scandinavia, Inc.collaborator
Study Sites (1)
Children's Hospital Boston and South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated prematurely by the IRB due to data integrity and compliance concerns. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.
Results Point of Contact
- Title
- Dr. Neil Feins
- Organization
- Children's Hospital Boston and South Shore Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Neil R. Feins, M.D.
Children's Hospital Boston and South Shore Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2008
First Posted
June 27, 2008
Study Start
April 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
November 6, 2017
Results First Posted
August 28, 2013
Record last verified: 2017-10