Clinical trial NCT06193551: Ovitex in Paraesophageal and Large Hiatal Hernia Repair
Official title: Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paraesophageal Hernia
Large Hiatal Hernia
Keywords: paraesophageal hiatal hernia
paraesphageal hernia
hiatal hernia
Lead sponsor: Foregut Research Foundation
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trial with a single arm of patients undergoing elective repair of paraesphageal hiatal hernia repair or large hiatal henia repair with implant of Ovitex-LPR.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm
timeFrame: 5 years
Secondary outcomes:
measure: Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy
timeFrame: 5 years
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Institute of Esophageal and Reflux Surgery
state: Colorado
Study officials:
affiliation: Foregut Research Foundation
name: Kate Freeman, MSN
role: STUDY_DIRECTOR
References: