BridgeMD
New treatment option for Hiatal Hernia
Official title Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
ClinicalTrials.gov ID: NCT07070115
What this study is testing
- What it's testing
- This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S...
- 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.
You likely can't join if
- (Baseline):
- 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.)
See the full eligibility criteria
- 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.
- (Baseline):
- 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).
- 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. Exclusion Criteria (Intra-operative):
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.