CompletedNot Applicable

ACELL Mesh for Paraesophageal Hernia Repair

United States65 participantsStarted 2016-02-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Rate of hernia recurrence

Timeframe: 12 months

Trial details

NCT IDNCT03058731

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-04-01

View on ClinicalTrials.gov More Paraesophageal Hernia trials