Ovitex in Paraesophageal and Large Hiatal Hernia Repair

ConditionsParaesophageal Hernia Large Hiatal Hernia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorForegut Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-85 year old with PEH and appropriate surgical indication for repair

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Ovitex LPR
Device
Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repairOther 1 intervention

Trial outcomes

Primary outcomes

Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm

Assess recurrence rates by objective measures when Ovitex LPR permanent polypropylene polymer reinforcement (Ovitex LPR) is placed during robotic-assisted repair of paraesophageal and large (\> 5cm) hiatal hernias (henceforth PEH) using recurrence rate measurements defined as \> 2cm axial hernia by Barium Swallow or endoscopy, if available

Time frame

5 years

Secondary outcomes

Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy

Assess the safety of using polypropylene support related to potential erosion as assessed by presence of symptoms using study quality of life questionnaire leading to endoscopy demonstrating mesh erosion

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Foregut Research Foundation

Lead sponsor

Source ClinicalTrials.gov

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