Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix
1 other identifier
observational
85
1 country
1
Brief Summary
Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 7, 2018
CompletedFirst Posted
Study publicly available on registry
November 8, 2018
CompletedResults Posted
Study results publicly available
August 5, 2019
CompletedOctober 1, 2019
September 1, 2019
1 year
November 7, 2018
June 17, 2019
September 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Who Required a Revision of the Index Surgery.
Patient self-report if they had a revision or other laparoscopic surgery following index procedure.
6-18 months post index procedure
Secondary Outcomes (2)
Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)
6-18 months post index procedure
Medication Use
6-18 months post index procedure
Other Outcomes (2)
Satisfaction With Procedure
6-18 Months post index procedure
Likelihood to Recommend
6-18 Months post index procedure
Study Arms (1)
Observations Group
Patients who have undergone a hiatal hernia repair with MIROMESH.
Interventions
Hiatal hernia repair with MIROMESH
Eligibility Criteria
Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
You may qualify if:
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Heartburn and Hernia Institute
Lorton, Virginia, 22079, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was a retrospectively identified cohort.
Results Point of Contact
- Title
- Head of Clinical Affairs
- Organization
- Miromatrix
Study Officials
- PRINCIPAL INVESTIGATOR
George K Gillian, M.D.
Virginia Heartburn and Hernia Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2018
First Posted
November 8, 2018
Study Start
June 1, 2017
Primary Completion
June 1, 2018
Study Completion
October 1, 2018
Last Updated
October 1, 2019
Results First Posted
August 5, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share