CompletedNot Applicable

SurgiMend Mesh at the Hiatus

United States9 participantsStarted 2020-03-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recurrence Rate

Timeframe: 6 months post surgery

Trial details

NCT IDNCT04282720

SponsorKettering Health Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-16

Results submitted2024-11-20

View on ClinicalTrials.gov More Hiatal Hernia trials