SurgiMend Mesh at the Hiatus

  • STATUS
    Recruiting
  • End date
    Mar 10, 2024
  • participants needed
    15
  • sponsor
    Kettering Health Network
Updated on 10 March 2022

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 IdentifierNCT04282720
SponsorKettering Health Network
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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