Paraesophageal HerniaOviPHeRNCT06193551
Ovitex in Paraesophageal and Large Hiatal Hernia Repair
A study testing Ovitex LPR in people with Paraesophageal Hernia and Large Hiatal Hernia, run by Foregut Research Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Paraesophageal Hernia, Large Hiatal Hernia
- What is being tested?
- Ovitex LPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 year old with PEH and appropriate surgical indication for repair
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute of Esophageal and Reflux Surgery
Lone Tree, Colorado, 80124
Kate Freeman, MSN, 303-788-7700, kate@iersurgery.com
Rachel Heidrick, BSN, 303-788-7700 ext. 241, rachel@iersurgery.com
About this study
Official title: Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
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.
Read the 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.
- Conditions
- Paraesophageal Hernia, Large Hiatal Hernia
- Being tested
- Ovitex LPR
- Keywords
- paraesophageal hiatal hernia, paraesphageal hernia, hiatal hernia
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovitex LPRDevice
Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair | Other | This is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators. Receives: Device: Ovitex LPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start19 Feb 2024
- Primary completionJan 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraesophageal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foregut Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Freeman, MSN, Study director, Foregut Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193551
- Sponsor's protocol ID
- TelaBio
- Acronym
- OviPHeR
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovitex in Paraesophageal and Large Hiatal Hernia Repair. (OviPHeR)
- ClinicalTrials.gov ID
- NCT06193551
- Acronym / sponsor ID
- OviPHeR / TelaBio
- Conditions
- Paraesophageal Hernia, Large Hiatal Hernia
- Keywords
- paraesophageal hiatal hernia, paraesphageal hernia, hiatal hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Foregut Research FoundationUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair | Other | Device: Ovitex LPRThis is a single arm, open label, nonrandomized study evaluating 100 subjects diagnosed with a paraesophageal or large hiatal hernia planning to undergo surgical repair with the study investigators. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-85 year old with PEH and appropriate surgical indication for repair
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ovitex LPRRobotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement. | Device | Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair |
Primary outcome
Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm
Time frame: 5 years
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
1 secondary outcome
Number of participants with treatment related mesh erosions as assessed by study quality of life questionnaire leading to endoscopy
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Related trials for Paraesophageal Hernia
Active, not recruiting
Gastropexy in the Repair of Patients With Paraesophageal Hernias
Paraesophageal Hernia
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
Hiatal Hernia
Not yet recruiting
Antireflux Surgery Without Preoperative Esophageal Manometry
GERD, Hiatal Hernia
Recruiting
Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
Hiatal Hernia, Paraesophageal, Hiatal Hernia Large
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Freeman, MSN study director
Foregut Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovitex LPR in people with Paraesophageal Hernia and Large Hiatal Hernia, run by Foregut Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Freeman, MSN (3037887700, kate@iersurgery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.