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Completed

NCT Number: NCT04282720

SurgiMend Mesh at the Hiatus

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.

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Key information

Conditions

Hiatal Hernia Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kettering Health Network - Grandview Medical Center

Dayton, Ohio, 45405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SurgiMend Mesh

Device

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

Primary outcomes

  1. Recurrence Rate

    Time frame: 6 months post surgery

    Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL.

Secondary outcomes

  1. Quality of Life Using GERD-HRQL Scale

    Time frame: 6 month post surgery

    GERD-HRQL was developed to measure the typical symptoms of GERD and the effect on a patient's quality of life. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. Total score is calculated by summing the individual scores to questions 1-15 with greatest possible score (worst symptoms) = 75 and lowest possible score (no symptoms) = 0. The total score is made up of two sub scores which addressed heartburn and regurgitation symptoms and are reported separately in a heartburn score and regurgitation score as well as the total GERD-HRQL score. The follow up scores were combined due to some participants not having specific follow up information.

Sponsors and collaborators

Lead sponsor

Kettering Health Network

Other

Collaborators

  • Integra LifeSciences Corporation

Registry information

Official study title

Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2020
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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