N/A
N=73
Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH
Hiatal Hernia With Gastroesophageal Reflux Disease · Gastroesophageal Reflux · GERD
Bottom Line
View on ClinicalTrials.gov: NCT03735862 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Subjects Who Required a Revision of the Index Surgery. — 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hepatic derived surgical matrix (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Miromatrix Medical Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Required a Revision of the Index Surgery. |
— | — |
| SECONDARY Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) |
7.1 | <0.001 sig |
| SECONDARY Medication Use |
7; 65 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study
Exclusion Criteria
- N/A
Data sourced from ClinicalTrials.gov (NCT03735862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.