Ovitex in Paraesophageal and Large Hiatal Hernia Repair

Part of paid clinical trials in Lone Tree, Colorado.

Sponsor
Foregut Research Foundation
Study ID
NCT06193551
Status
Recruiting
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Conditions

  • Large Hiatal Hernia
  • Paraesophageal Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Ovitex LPR — DEVICE
    Robotic assisted laparoscopic repair of hiatal hernia using permanent sutures with Ovitex mesh as reinforcement.

Study Details

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.

Key Dates

Start date
Feb 19, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Patients undergoing a paraesophageal or large (>5 cm) hiatal hernia repair
    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.

Primary Outcome Measure

Hiatal Hernia Recurrence as assessed by barium swallow demonstrating axial hernia >2 cm [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute of Esophageal and Reflux SurgeryLone TreeColorado80124
Kate Freeman, MSN
[email protected]
303-788-7700
Rachel Heidrick, BSN
[email protected]
303-788-7700
Philip Woodworth, M.D. (PRINCIPAL_INVESTIGATOR)
Reginald Bell, M.D. (SUB_INVESTIGATOR)

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