NCT04282720

SurgiMend Mesh at the Hiatus

Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Kettering Health Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hiatal Hernia

Interventions

Type	Name	Description
DEVICE	SurgiMend Mesh	Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members

Timeline

• Start date: 2020-03-31
• Primary completion: 2023-08-16
• Completion: 2023-09-05
• First posted: 2020-02-25
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study