Hiatal HerniaECH2O2NCT07070115
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
A study testing OviTex Reinforced Tissue Matrix in people with Hiatal Hernia, run by Tela Bio Inc at 5 sites in United States.
Trial summary
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hiatal Hernia
- What is being tested?
- OviTex Reinforced Tissue Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jul 2025to 31 Jul 2032
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable.
- Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.
- Patient is at least 22 years old at the time of surgery.
- Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).
- Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.
Who cannot join
- Patient has a Body Mass Index (BMI) of ≥ 35.
- Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
- Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).
- Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
- Patient is a current nicotine user (including smokeless, vaporized, etc.)
- Patient has a history of illicit drug or alcohol abuse (in the last three years).
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- Patient has an allergy to ovine-derived products or a known sensitivity to polyglycolic acid (PGA).
- Patient has an allergy to barium.
- Patient's surgery will include the use of an anti-reflux implantable device (LINX, etc.).
- Patient's surgery requires the use of an additional mesh device or a pledget for reinforcement.
- Patient has participated in another gastrointestinal (GI) clinical study within the past 30 days or is currently involved in another clinical study excluding observational and registry studies.
- Patient had previous surgery at the gastroesophageal junction.
- Patient had a prior hiatal hernia repair.
- Patient has an incarcerated hernia that requires emergent intervention.
- Patient is a prisoner.
- Patient is unable to receive OviTex Core Resorbable or OviTex 1S Resorbable at time of surgery.
- Surgery requires the use of an additional mesh device or a pledget for reinforcement.
- Surgery includes the use of an anti-reflux implantable device (LINX, etc.).
- Surgery performed as an open procedure.
- Patient has a condition, which in the Investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's participation in the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
The University of Texas at Austin - Dell Medical School
Austin, Texas, 78712
Swetha Venkataraman, 512-495-2201, swetha.venkataraman@austin.utexas.edu
F.P. Tripp Buckley III, MD, FACS, FAFS
- Recruiting
Wake Forest University Health Sciences
Charlotte, North Carolina, 28204
Gregory Scarola, MS, MBA, 704-355-5766, Gregory.Scarola@advocatehealth.org
Paul Colavita, MD
- Recruiting
SurgOne, PC
Denver, Colorado, 80210
Cassandra Ault, 303-765-6839, cassandra.ault@adventhealth.com
Ahmed Zihni, MD
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Sydney Cloyd, BSN, RN, 859-218-5151, Sydney.Cloyd@uky.edu
J. Scott Roth, MD
- Recruiting
University of South Alabama Health
Mobile, Alabama, 36617
Valrie Patterson, RN, 251-445-9626, valriepatterson@health.southalabama.edu
William O Richards, MD
About this study
Official title: A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Read the detailed description
This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 173 subjects in the United States. Patients undergoing an elective hiatal hernia repair and who meet all eligibility criteria will be enrolled in the study. Subjects will undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement. Subjects will have clinical follow-up through 5 years. Data collected in this study will be compared to a literature control at 24 months.
- Conditions
- Hiatal Hernia
- Being tested
- OviTex Reinforced Tissue Matrix
- Keywords
- hiatal, hernia, reinforced tissue matrix
- Medical subject headings
- Hernia, Hiatal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OviTex Reinforced Tissue MatrixDevice
All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.
| Study group | Role | What they receive |
|---|---|---|
| OviTex Reinforced Tissue Matrix | Other | This is a single-arm study. All study subjects will receive OviTex. Receives: Device: OviTex Reinforced Tissue Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
Incidence of radiographic recurrence at 24 months, defined as > 2cm above the hiatus via barium swallow.
Measured: At 24 months
Secondary outcomes (1)
Early post-operative complications
Incidence of early post-operative device-related complications noted at the hernia repair site occurring ≤ 90 days after index hiatal hernia repair
Measured: Occurring within the first 3 months of the hiatal hernia repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start25 Jul 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hiatal 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
- Masking
- None (open label)
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tela Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070115
- Sponsor's protocol ID
- TB_04
- Acronym
- ECH2O2
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix
- ClinicalTrials.gov ID
- NCT07070115
- Acronym / sponsor ID
- ECH2O2 / TB_04
- Conditions
- Hiatal Hernia
- Keywords
- hiatal, hernia, reinforced tissue matrix
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Tela Bio IncIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 17 Jul 2025 (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.
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Detailed description
This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 173 subjects in the United States. Patients undergoing an elective hiatal hernia repair and who meet all eligibility criteria will be enrolled in the study. Subjects will undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement. Subjects will have clinical follow-up through 5 years. Data collected in this study will be compared to a literature control at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OviTex Reinforced Tissue Matrix | Other | Device: OviTex Reinforced Tissue MatrixThis is a single-arm study. All study subjects will receive OviTex. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable.
- Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.
- Patient is at least 22 years old at the time of surgery.
- Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).
- Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.
Key exclusion criteria (20 listed)
- Patient has a Body Mass Index (BMI) of ≥ 35.
- Patient meets the Centers for Disease Control (CDC) Surgical Site Infection (SSI) Wound Classification Class IV (Dirty-Infected) criteria.
- Patient has a Type I hiatal hernia (defined as only the esophagogastric junction is above the diaphragm).
- Patient has a life expectancy of less than five years making it unlikely that the subject will successfully achieve five-year follow-up.
- Patient is a current nicotine user (including smokeless, vaporized, etc.)
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 Reinforced Tissue MatrixAll study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists. | Device | OviTex Reinforced Tissue Matrix |
Primary outcome
Hernia recurrence
Time frame: At 24 months
Incidence of radiographic recurrence at 24 months, defined as > 2cm above the hiatus via barium swallow.
1 secondary outcome
Early post-operative complications
Time frame: Occurring within the first 3 months of the hiatal hernia repair
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 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hiatal Hernia
Active, not recruiting
Gastropexy in the Repair of Patients With Paraesophageal Hernias
Paraesophageal Hernia
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Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
Active, not recruiting
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
GERD, Hiatal Hernia
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OviTex Reinforced Tissue Matrix in people with Hiatal Hernia, run by Tela Bio Inc at 5 sites 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 5 inclusion and 20 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Melissa LaMantia, MA (757-761-4922, mlamantia@telabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence (time frame: At 24 months). 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 18 Aug 2026.