SurgiMend Mesh at the Hiatus

Completed · Not applicable

Conditions studied: Hiatal Hernia

In brief

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.

Key facts

Study ID

NCT04282720

Run by

Kettering Health Network

People needed

9

Starts

2020-03-31

Expected to finish

2023-09-05

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of type 3 or 4 hiatal hernia (8)
• Subject is able to give informed consent
• Adults at least 18 years of age

You may not qualify if…

• Currently pregnant
• Prior hiatal hernia repair
• Prior gastric surgery
• Prior foregut surgery
• Known esophageal dysfunction or dysmotility
• Cirrhosis or ascites
• Known malignancy
• Known allergy to biologic mesh
• Known allergy to barium or other contrast material used in UGI
• Religious objection to animal implant
• Cognitive impairment
• Prisoners

Where it is running

• Kettering Health Network - Grandview Medical Center — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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