A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch (Panacea)
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ClinicalTrials.gov Identifier: NCT01848184 |
Recruitment Status :
Completed
First Posted : May 7, 2013
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
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Sponsor:
Medtronic - MITG
Information provided by (Responsible Party):
Medtronic - MITG
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Study Type | Observational |
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Study Design | Observational Model: Cohort; Time Perspective: Prospective |
Condition |
Hernia |
Intervention |
Device: PARIETEX™ Composite Ventral Patch |
Enrollment | 126 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | PARIETEX™ Composite Ventral Patch |
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PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning PARIETEX™ Composite Ventral Patch for ventral hernia repair |
Period Title: Overall Study | |
Started | 126 |
Completed | 100 |
Not Completed | 26 |
Baseline Characteristics
Arm/Group Title | PARIETEX™ Composite Ventral Patch | |
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PARIETEX™ Composite Ventral Patch for primary ventral hernia repair by open approach with intra-peritoneal positioning PARIETEX™ Composite Ventral Patch for ventral hernia repair |
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Overall Number of Baseline Participants | 126 | |
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Consented and enrolled population 126 (100.0) Completed Study 100 (79.4) Discontinued early 26 (20.6)
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 126 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
107 84.9%
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>=65 years |
19 15.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 126 participants | |
51.2 (12.21) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 126 participants | |
Female |
39 31.0%
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Male |
87 69.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 126 participants |
Sweden | 15 | |
Belgium | 40 | |
United States | 33 | |
Denmark | 16 | |
Italy | 11 | |
Netherlands | 11 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Michelle DiSalvo |
Organization: | Medtronic |
Phone: | 774 284 6089 |
EMail: | michelle.v.disalvo@medtronic.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medtronic - MITG |
ClinicalTrials.gov Identifier: | NCT01848184 |
Other Study ID Numbers: |
COVPCOV0293 |
First Submitted: | May 2, 2013 |
First Posted: | May 7, 2013 |
Results First Submitted: | October 4, 2017 |
Results First Posted: | July 20, 2018 |
Last Update Posted: | July 20, 2018 |