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SurgiMend Mesh for Hiatal Hernia
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.
- Hiatal Hernia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a specific type of hernia called type 3 or 4 hiatal hernia.You have a religious belief that prohibits the use of animal implants.You have had surgery to repair a hiatal hernia in the past.You had a surgery on your stomach before.You have had surgery on your upper digestive system before.You have a liver condition called cirrhosis or ascites.You have a problem with how your esophagus works or moves.You have problems with thinking or memory.You are currently expecting a baby.You are allergic to the material used in the biologic mesh.
- Group 1: SurgiMend Mesh
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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