Gastro-oesophageal Reflux Disease Trial, Recruiting NCT03669874 Sponsor: IRCCS San Raffaele Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT03669874
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have had symptoms of acid reflux (GERD) — either in the oesophagus (such as heartburn) or in other areas like the throat or lungs — for more than 6 months
  • People who have had a test (endoscopy or pH-impedance study) confirming acid reflux or related oesophageal conditions, such as oesophagitis, Barrett's oesophagus, or a sensitive oesophagus
  • People for whom a surgeon has recommended a surgical procedure called fundoplication to treat their acid reflux
  • People who are able to attend follow-up appointments over a long period of time

Who may not be able to join:

  • People who have a hiatal hernia (where part of the stomach pushes up through the diaphragm) measuring 3 cm or larger
  • People who have a significant problem with the movement or muscle function of the oesophagus
  • People who have a narrowing of the oesophagus
  • People who have been diagnosed with cancer (except for minor, superficial skin cancers)
  • People who have high blood pressure in the liver's blood vessels, bleeding problems that would make surgery unsafe, swollen veins in the oesophagus, or narrowing or pouches in the oesophagus
  • People who have previously had surgery on the heart, chest, or upper digestive system
  • People with a BMI (body mass index) over 40
  • People who are pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Pier Alberto Testoni, Professor, San Raffaele Scientific Institute

Phone: +390226432756

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
IRCCS San Raffaele
Registry
ClinicalTrials.gov
Start date
16 September 2015
Est. completion
16 September 2021

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score; To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score; To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score; To evaluate clinical effica...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov