SurgiMend Mesh at the Hiatus

October 4, 2023 updated by: Kettering Health Network

Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Dayton, Ohio, United States, 45405
        • Kettering Health Network - Grandview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SurgiMend Mesh

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.
Device: SurgiMend Mesh
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Using GERD-HRQL Scale
Time Frame: pre-operative and 3 month and 6 month post surgery
The GERD-HRQL was initially developed to measure the typical symptoms of GERD and their effect on a patient's quality of life. It was initially determined to have face validity and subsequent studies assessed its content validity and criterion validity. Reliability was determined by the test-retest method. This instrument is practical, with little administrative burden and has been validated for use via the telephone call. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating.
pre-operative and 3 month and 6 month post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kettering Health Network

Collaborators

Integra LifeSciences Corporation

Investigators

  • Principal Investigator: Paul Levy, DO, Kettering Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2020

Primary Completion (Actual)

August 16, 2023

Study Completion (Actual)

September 5, 2023

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SurgiMend

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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