BridgeMD
New treatment option for Paraesophageal Hernia
Official title Ovitex in Paraesophageal and Large Hiatal Hernia Repair
ClinicalTrials.gov ID: NCT06193551
What this study is testing
- What it's testing
- The purpose of the study is to evaluate the success of hiatal hernia repairs in patients with large (\>5cm) or paraesophageal hernias when Ovitex LPR mesh used during the repair.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 18-85 year old with PEH and appropriate surgical indication for repair
You likely can't join if
- Under 22 years of age.
- In need of an emergency procedure.
- Currently being treated with another investigational drug or device.
- Have had prior gastric or esophageal surgery.
- Have had any previous intervention for GERD.
- Are suspected or confirmed to have esophageal or gastric cancer.
See the full eligibility criteria
- 18-85 year old with PEH and appropriate surgical indication for repair
- Under 22 years of age.
- In need of an emergency procedure.
- Currently being treated with another investigational drug or device.
- Have had prior gastric or esophageal surgery.
- Have had any previous intervention for GERD.
- Are suspected or confirmed to have esophageal or gastric cancer.
- Have a Body Mass Index (BMI) greater than 45.
- Cannot understand trial requirements or are unable to comply with follow-up schedule.
- Are pregnant, nursing, or plan to become pregnant.
- Have a mental health disorder that would interfere with your ability to follow study instructions.
- Have suspected or known allergies to Ovitex
- Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.
The study team makes the final eligibility decision.
Where it's taking place
- Lone Tree, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lone Tree, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.