LINX versus fundoplication for treating gastro-oesophageal reflux (GERD)
Double-blind Randomised Controlled Trial for Treatment of Gastro-Oesophageal Reflux Disease; LINX Management System vs. Fundoplication (GOLF)
This trial will test whether the LINX magnetic ring or traditional fundoplication works better for adults with reflux (GERD) who need surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 5 sites (Oxford, Oxfordshire and 4 other locations) |
| Trial ID | NCT07093359 on ClinicalTrials.gov |
What this trial studies
Adults with symptomatic, objectively confirmed gastro-oesophageal reflux disease who are being considered for anti-reflux surgery are offered either a laparoscopic or robotic LINX device or a laparoscopic or robotic fundoplication. Eligible participants must be 18 or older, have objective evidence of reflux, a hiatal hernia no larger than 5 cm, and adequate oesophageal motility, while prior anti-reflux surgery excludes patients. The trial compares symptom control, quality of life, and surgical complications such as gas bloat and swallowing difficulty between the two surgical approaches. The programme is led by the University of Oxford in collaboration with major UK centres.
Who should consider this trial
Good fit: Adults (≥18) with symptomatic, objectively confirmed GORD who are inadequately controlled by or intolerant of medical therapy, have a hiatal hernia ≤5 cm, adequate oesophageal motility, are fit for general anaesthesia, and have no prior anti-reflux surgery.
Not a fit: Patients with large hiatal hernias (>5 cm), poor oesophageal motility, previous anti-reflux or gastric surgery, allergies to device metals, or who are unfit for general anaesthesia are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, LINX could provide similar reflux control to fundoplication with fewer side effects such as gas bloating and difficulty swallowing.
How similar studies have performed: Previous studies suggest LINX may reduce some complications and offer similar quality-of-life improvement compared with fundoplication, but high-quality comparative evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years and above 2. Willing and able to give informed consent 3. Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery 4. Symptomatic and objectively defined GORD; endoscopy with appearances or biopsies consistent with reflux oesophagitis, or 24-hour pH study or BRAVO test of the oesophagus consistent with GORD 5. No hiatal hernia or hiatal hernia \<5 cm in length 6. Adequate lower oesophageal motility as defined by preoperative oesophageal manometry study. Oesophageal manometry will show a mean contractile amplitude of \>30 mmHg or DCI \>450 mmHg-s-cm in 70% of swallows. Exclusion Criteria: 1. Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia 2. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials 3. Previous anti-reflux or gastric surgery 4. Previous or planned neurosurgical intervention 5. Oesophageal manometry showing complete absence of lower oesophageal contractility
Where this trial is running
Oxford, Oxfordshire and 4 other locations
- Guy's and St Thomas's NHS Foundation Trust, Guy's and St Thomas's Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust, St Mary's Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
- Leeds Teaching Hospitals NHS Trust, St James's University Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust, Churchill Hospital — Oxford, Oxfordshire, United Kingdom (Recruiting)
- University Hospital Southampton NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sheraz Markar, PhD, FRCS, MSc, MA
- Email: golf@nds.ox.ac.uk
- Phone: +44 07584039433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.