BridgeMD
Compares treatment options for Gastro-oesophageal Reflux Disease
Official title LINX vs Fundoplication
ClinicalTrials.gov ID: NCT07093359
What this study is testing
- What it's testing
- Reflux disease can severely impact upon quality-of-life and lead to complications, including ulceration of the oesophagus. It is often controlled with self-help measures and medication.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years and above
- Willing and able to give informed consent
- Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery
- Symptomatic and objectively defined GORD; endoscopy with appearances or biopsies consistent with reflux oesophagitis, or 24-hour pH study or BRAVO...
- No hiatal hernia or hiatal hernia \<5 cm in length
You likely can't join if
- Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia
- Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials
- Previous anti-reflux or gastric surgery
- Previous or planned neurosurgical intervention
- Oesophageal manometry showing complete absence of lower oesophageal contractility
See the full eligibility criteria
- Age 18 years and above
- Willing and able to give informed consent
- Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery
- 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
- No hiatal hernia or hiatal hernia \<5 cm in length
- 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.
- Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia
- Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials
- Previous anti-reflux or gastric surgery
- Previous or planned neurosurgical intervention
- Oesophageal manometry showing complete absence of lower oesophageal contractility
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, Oxfordshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.