Paraesophageal Hernia study: OviTex Mesh
Official title Mesh Vs Pledgets for Repair of Paraesophageal Hernia
ClinicalTrials.gov ID: NCT05974722
What this study is testing
- What it's testing
- The study compares 2‑year recurrence rates and quality of life after hernia repair using Ovitex mesh versus pledgeted sutures.
- Who it's for
- Adults who have had a paraesophageal hernia repair at the Cleveland Clinic.
- What's involved
- Participants will receive either Ovitex mesh or pledgeted sutures during surgery, then have follow‑up visits and imaging to check for recurrence and report on quality of life.
- Time commitment
- The study lasts 2 years with scheduled follow‑up visits and imaging at specified times after surgery.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older
- Willing and able to provide informed consent
- Willing and able to participate in long-term follow up including study visits and surveys
- Type II, III, or IV hiatal hernia \> 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively
You likely can't join if
- Pregnancy
- BMI \>45
- Allergy to any components of mesh
- Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to reduce stomach volume (sleeve gastrectomy, roux-en-y gastric...
- Patients who have undergone previous hiatal hernia repair
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, 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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.