SurgiMend Mesh at the Hiatus

Kettering Health Network

Status: Completed

Conditions: Hiatal Hernia

Treatments: Device: SurgiMend Mesh

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04282720

SurgiMend

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

SurgiMend Mesh

Other group

Description:

SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Treatment:

Device: SurgiMend Mesh