Umbilical HerniaMICNCT00706329
Minimally Invasive Closure of Umbilical Hernias
A study testing Deflux in people with Umbilical Hernia, run by South Shore Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- Deflux
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Over 5 years
- No umbilical hernia
- No other surgery required
- Previous umbilical hernia repair
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston and South Shore Hospital
South Weymouth, Massachusetts, 02190
About this study
Official title: 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.
Read the 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.
- Conditions
- Umbilical Hernia
- Being tested
- Deflux
- Keywords
- Minimally invasive surgery, Umbilical hernia, Infant
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefluxDevice
Patients undergo surgery using Deflux to correct umbilical hernia
| Study group | Role | What they receive |
|---|---|---|
| Deflux | Experimental | Treatment with Deflux. Receives: Device: Deflux |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After surgery, subjects will be followed at intervals of one month and six months from date of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: The study was terminated prematurely by the IRB due to data integrity and protocol compliance issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Shore Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Q-Med Scandinavia, Inc.
- Responsible party
- Sponsor
- Investigators
- Neil R. Feins, M.D., Principal investigator, Children's Hospital Boston and South Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706329
- Sponsor's protocol ID
- SSH ID 07-003
- Acronym
- MIC
- Status last verified
- Oct 2017
- First submitted
- 25 Jun 2008
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Minimally Invasive Closure of Umbilical Hernias
- ClinicalTrials.gov ID
- NCT00706329
- Acronym / sponsor ID
- MIC / SSH ID 07-003
- Conditions
- Umbilical Hernia
- Keywords
- Minimally invasive surgery, Umbilical hernia, Infant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely by the IRB due to data integrity and protocol compliance issues
- Enrolment
- 25 participants (actual)
- Lead sponsor
- South Shore HospitalUniversity, hospital or other
- Collaborators
- Q-Med Scandinavia, Inc.
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 28 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deflux | Experimental | Device: DefluxTreatment with Deflux. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Over 5 years
- No umbilical hernia
- No other surgery required
- Previous umbilical hernia repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DefluxPatients undergo surgery using Deflux to correct umbilical hernia | Device | Deflux |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil R. Feins, M.D. principal investigator
Children's Hospital Boston and South Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deflux in people with Umbilical Hernia, run by South Shore Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.