SurgiMend Mesh at the Hiatus
-
- STATUS
- Recruiting
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- End date
- Mar 10, 2024
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- participants needed
- 15
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- sponsor
- Kettering Health Network
Summary
Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data.
Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.
Details
| Condition | Hiatal Hernia |
|---|---|
| Treatment | SurgiMend Mesh |
| Clinical Study Identifier | NCT04282720 |
| Sponsor | Kettering Health Network |
| Last Modified on | 10 March 2022 |
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