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Biological Mesh

SurgiMend Mesh for Hiatal Hernia

N/A
Waitlist Available
Led By Paul Levy, DO
Research Sponsored by Kettering Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of type 3 or 4 hiatal hernia (8)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative and 3 month and 6 month post surgery
Awards & highlights

Study Summary

This trial is to study subjects who have had surgery for a hiatal hernia using a SurgiMend biological mesh, in order to see if there is a re-occurrence and what the quality of life is like.

Eligible Conditions
  • Hiatal Hernia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a specific type of hernia called type 3 or 4 hiatal hernia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative and 3 month and 6 month post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative and 3 month and 6 month post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence Rate
Secondary outcome measures
Quality of Life Using GERD-HRQL Scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: SurgiMend MeshExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
SurgiMend Mesh
2020
N/A
~10

Find a Location

Who is running the clinical trial?

Kettering Health NetworkLead Sponsor
19 Previous Clinical Trials
1,848 Total Patients Enrolled
Integra LifeSciences CorporationIndustry Sponsor
84 Previous Clinical Trials
9,480 Total Patients Enrolled
Paul Levy, DOPrincipal InvestigatorKettering Health Network

Media Library

SurgiMend Mesh (Biological Mesh) Clinical Trial Eligibility Overview. Trial Name: NCT04282720 — N/A
Hiatal Hernia Research Study Groups: SurgiMend Mesh
Hiatal Hernia Clinical Trial 2023: SurgiMend Mesh Highlights & Side Effects. Trial Name: NCT04282720 — N/A
SurgiMend Mesh (Biological Mesh) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04282720 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What upper limit has been established for patient participation in this trial?

"Confirmed, the information accessible on clinicaltrials.gov suggests that this research initiative is currently recruiting participants. The trial was first published on March 31st 2020 and has been updated most recently on March 3rd 2022; 15 patients are required for recruitment at a single location."

Answered by AI

Are there any opportunities to volunteer for this experiment?

"Affirmative. This medical experiment is currently accepting participants, as indicated by the online repository of clinical trials information. The study was first announced on March 31st 2020 and has been recently revised for accuracy on 3rd March 2021. 15 individuals need to be sourced from a single site for this trial."

Answered by AI
Recent research and studies
~2 spots leftby Mar 2025