ACELL Mesh for Paraesophageal Hernia Repair
Completed
Conditions studied: Paraesophageal Hernia
In brief
This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.
Key facts
- Study ID
- NCT03058731
- Run by
- University of South Florida
- People needed
- 65
- Starts
- 2016-02-02
- Expected to finish
- 2019-01-28
- Last updated by the study team
- 2019-03-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years and older
- Underwent primary or re-do PEHR with biological mesh by Dr. Vic Velanovich or Dr. Michael Albrink between June 1, 2012 and September 30, 2016
- Written informed consent obtained from subject prior to esophagogram procedure and ability for subject to comply with the requirements of the study
You may not qualify if…
- Age < 18 years of age
- Underwent PEHR by a surgeon other than Dr. Vic Velanovich or Dr. Michael Albrink
- Underwent PEHR outside of the timeframe of June 1, 2012 and September 30, 2016
- Subject is involved in ongoing medical litigation, confirmed via subject report
- Subject is incarcerated, confirmed via subject report
- Pregnant
Where it is running
- Tampa General Hospital — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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