Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
ConditionHiatal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorTela Bio Inc
About this trial
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
OviTex Reinforced Tissue Matrix
DeviceAll 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.
Treatment groups
173 Participants
are divided into 1 treatment groupGroup A: OviTex Reinforced Tissue MatrixOther 1 intervention
Trial outcomes
Primary outcomes
1
Hernia recurrence
Incidence of radiographic recurrence at 24 months, defined as \> 2cm above the hiatus via barium swallow.
Time frame
At 24 monthsSecondary 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
Time frame
Occurring within the first 3 months of the hiatal hernia repairSponsors and contacts
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Source ClinicalTrials.gov