RECRUITING

Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-19
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06193551

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-85 year old with PEH and appropriate surgical indication for repair
  1. * Under 22 years of age.
  2. * In need of an emergency procedure.
  3. * Currently being treated with another investigational drug or device.
  4. * Have had prior gastric or esophageal surgery.
  5. * Have had any previous intervention for GERD.
  6. * Are suspected or confirmed to have esophageal or gastric cancer.
  7. * Have a Body Mass Index (BMI) greater than 45.
  8. * Cannot understand trial requirements or are unable to comply with follow-up schedule.
  9. * Are pregnant, nursing, or plan to become pregnant.
  10. * Have a mental health disorder that would interfere with your ability to follow study instructions.
  11. * Have suspected or known allergies to Ovitex
  12. * Have an illness that may cause you to be unable to meet the protocol requirements or is associated with shortened life expectancy.

Contacts and Locations

Study Contact

Kate Freeman, MSN
CONTACT
3037887700
kate@iersurgery.com

Principal Investigator

Kate Freeman, MSN
STUDY_DIRECTOR
Foregut Research Foundation

Study Locations (Sites)

Institute of Esophageal and Reflux Surgery
Lone Tree, Colorado, 80124
United States

Collaborators and Investigators

Sponsor: Foregut Research Foundation

  • Kate Freeman, MSN, STUDY_DIRECTOR, Foregut Research Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-19
Study Completion Date2030-06

Study Record Updates

Study Start Date2024-02-19
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • paraesophageal hiatal hernia
  • paraesphageal hernia
  • hiatal hernia

Additional Relevant MeSH Terms

  • Paraesophageal Hernia
  • Large Hiatal Hernia