Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair (NCT04795934)
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair Combined With Transoral Incisionless Fundoplication Versus Laparoscopic Nissen Fundoplication for Treatment of Gastroesophageal Reflux Disease in Patients Requiring Hiatal Hernia Repair
🩺 Plain-English Summary (8th-Grade Level)
This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.
Who can join: Review the eligibility criteria below.
Location: University of California Irvine — Irvine, California
Age range: 22 Years to 80 Years
🧪 Interventions in This Study
- LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- University of California Irvine — Irvine, California
- University of Southern California — Los Angeles, California
- Institute of Esophageal and Reflux Surgery — Englewood, Colorado
- Mayo Clinic in Rochester — Rochester, Minnesota
- The University of Texas at Austin — Austin, Texas
- University of Texas Health Science Center at Houston — Houston, Texas
- Fox Valley Surgical — Appleton, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in GERD
- Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy — Baltimore, Maryland
- PROPER-GERD: A Prospective Crossover Study to Evaluate Probe Placement Optimization for Reflux Testing in Women and Lower-BMI Patients — Chicago, Illinois
- Antireflux Surgery Without Preoperative Esophageal Manometry — Cleveland, Ohio
- Mechanisms Preventing Pharyngeal Reflux — Milwaukee, Wisconsin
- Compassionate Use of Domperidone for Refractory Gastroparesis — Kansas City, Missouri
Explore by condition: All GERD clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.