Status:
COMPLETED
SurgiMend Mesh at the Hiatus
Lead Sponsor:
Kettering Health Network
Collaborating Sponsors:
Integra LifeSciences Corporation
Conditions:
Hiatal Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Diagnosis of type 3 or 4 hiatal hernia (8)
- Subject is able to give informed consent
- Adults at least 18 years of age
Exclusion
- 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
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04282720
Start Date
March 31 2020
End Date
September 5 2023
Last Update
October 5 2023
Active Locations (1)
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1
Kettering Health Network - Grandview Medical Center
Dayton, Ohio, United States, 45405