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NCT04795934 · ClinicalTrials.gov registry record · NA
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
A NA study of GERD and Hiatal Hernia, sponsored by Mayo Clinic.
- Active
- Registry status
- NA
- Development phase
- 142
- Enrollment target
- 7
- Study locations
NCT04795934: Active NA study of GERD and Hiatal Hernia, sponsored by Mayo Clinic.
NCT04795934 is a NA study of GERD and Hiatal Hernia that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 142 participants, below the 158-participant average among 15 other GERD trials with a reported enrollment target (10% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04795934, a NA study of GERD and Hiatal Hernia, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 142 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
Hypothesis: TIF is non-inferior to LNF as measured by quality of life at 6 months post-procedure using the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) score. GERD-HRQL Scoring Total Score: Calculated by summing the individual scores to questions 1-15. * Greatest possible score (worst symptoms) = 75 * Lowest possible score (no symptoms) = 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . * Worst heartburn symptoms = 30 * No heartb
Conditions Studied
Interventions
- PROCEDURE LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION
Study Locations (7)
California
- University of California Irvine - Irvine
- University of Southern California - Los Angeles
Texas
- The University of Texas at Austin - Austin
- University of Texas Health Science Center at Houston - Houston
Colorado
- Institute of Esophageal and Reflux Surgery - Englewood
Minnesota
- Mayo Clinic in Rochester - Rochester
Wisconsin
- Fox Valley Surgical - Appleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2030-01 |
| Phase | NA |
What the registry record for NCT04795934 still lists
NCT04795934 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 158-participant average among 15 other GERD trials with a reported enrollment target (10% lower).
The record links to 2 conditions, with GERD appearing as the primary indexed condition, and to 1 intervention - of which LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION is the first listed.
NCT04795934 lists 7 locations in 5 states (California, Texas, Colorado).
Frequently Asked Questions
What is clinical trial NCT04795934 about?
NCT04795934 is a clinical study titled "Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair". 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.
What is the current status of trial NCT04795934?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 142 participants. The study started on 2021-01-26. Estimated completion is 2030-01.
What conditions does trial NCT04795934 study?
This clinical trial studies the following conditions: GERD, Hiatal Hernia.
What interventions are being tested in trial NCT04795934?
The interventions under investigation include: LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION (PROCEDURE).
Who is sponsoring clinical trial NCT04795934?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04795934 being conducted?
This trial has 7 study locations across California, Colorado, Minnesota, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04795934's enrollment target sits among peer trials
142 6th of 15 higher than 10 of 15 other GERD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other GERD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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