Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Paraesophageal Hernia Clinical Trial

— OviPHeR  

Official title:

Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193551
• Other study ID #: TelaBio
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: June 2030

Study information

• Verified date: March 2024
• Source: Foregut Research Foundation
• Contact: Kate Freeman, MSN
• Phone: 3037887700
• Email: kate[@]iersurgery.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is an investigator initiated, single site, single arm study investigating the recurrence rate of hiatal hernia and safety using Ovitex LPR in patients undergoing hiatal hernia repair.

Ovitex LPR mesh is a reinforced tissue matrix, comprised of a fine non-absorbable polymer suture interwoven through layers of absorbable biologic material in a "lockstitch" pattern.The biologic material in OviTex, derived from ovine rumen (sheep stomach), serves as the natural building block and is optimized to reduce foreign body response, enable functional tissue remodeling and promote a more natural hernia repair. The interwoven polymer fibers provide additional reinforcement, along with improved handling and load-sharing capability. The permanent polymer fiber (polypropylene) is a standard surgical suture material that is used in hiatal hernia surgery and comprises less than 5% of the final product.

Preop details, quality of life questionnaires and surgery details will be collected along with post op GERD (gastro esophageal reflux disease) quality of life questionnaires and barium swallow esophagrams to objectively examine recurrence of hiatal hernia at 1, 3, and 5 years post op. Data will be carefully collected and reviewed for discrepancies and verified with source prior to analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Hiatal
• Paraesophageal Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Institute of Esophageal and Reflux Surgery	Lone Tree	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Foregut Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years
Secondary	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	5 years