Trials / Active Not Recruiting
Active Not RecruitingNCT04795934
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 22 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION | LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION |
Timeline
- Start date
- 2021-01-26
- Primary completion
- 2025-07-31
- Completion
- 2030-01-01
- First posted
- 2021-03-12
- Last updated
- 2025-08-19
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04795934. Inclusion in this directory is not an endorsement.