Trial Outcomes & Findings for Minimally Invasive Closure of Umbilical Hernias (NCT NCT00706329)
NCT ID: NCT00706329
Last Updated: 2017-11-06
Results Overview
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.
TERMINATED
NA
25 participants
After surgery, subjects will be followed at intervals of one month and six months from date of surgery.
2017-11-06
Participant Flow
physician office
59 medical records were screened; 25 were eligible and received Deflux
Participant milestones
| Measure |
Deflux
Treatment with Deflux.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minimally Invasive Closure of Umbilical Hernias
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Deflux
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Neil Feins
Children's Hospital Boston and South Shore Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place