Gastro-oesophageal Reflux Disease Trial, Recruiting NCT03961945 Sponsor: Mayo Clinic Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT03961945
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:

Group 1 (Aim 1 – people being screened for Barrett's Esophagus):

  • Adults between the ages of 50 and 85
  • People who have three or more known risk factors for a condition called Barrett's Esophagus
  • People who have been diagnosed with acid reflux disease, OR have taken certain acid-reducing medications (such as omeprazole, pantoprazole, ranitidine, or similar drugs) for 3 months or more over the past 5 years, OR have previously been told they have inflammation/damage in their food pipe (erosive esophagitis)
  • People with a Body Mass Index (BMI) of 30 or higher (confirm with trial site)

Group 2 and 3 (Aims 2 & 3 – people with known or suspected Barrett's Esophagus, and comparison group):

  • Adults between the ages of 18 and 90 who have known or suspected Barrett's Esophagus, where the affected area of the food pipe is at least 1cm long, or where medical records indicate suspected Barrett's Esophagus
  • People whose tissue samples have shown a specific type of cell change in the food pipe lining, with or without pre-cancerous changes, or where medical records suggest suspected Barrett's Esophagus
  • People who are already scheduled to have an endoscopy (a camera examination of the food pipe) for a medical reason
  • People without a history of Barrett's Esophagus who are already scheduled to have a diagnostic endoscopy for a medical reason

Who may not be able to join:

Group 1 (Aim 1):

  • People with a history of cancer of the food pipe (either adenocarcinoma or squamous carcinoma)
  • People who have previously had a procedure to remove or destroy abnormal tissue in the food pipe due to Barrett's Esophagus
  • People with a history of pre-cancerous cell changes in the food pipe (squamous dysplasia)
  • People currently taking blood-thinning medications such as Warfarin or Coumadin
  • People with a history of liver cirrhosis (serious liver scarring)
  • People with a history of enlarged veins in the food pipe or stomach (varices)
  • People who have previously been diagnosed with Barrett's Esophagus
  • People who have had a camera examination of the food pipe (endoscopy) in the last 5 years

Groups 2 and 3 (Aims 2 & 3):

  • People with Barrett's Esophagus who have previously had certain procedures to destroy abnormal tissue in the food pipe, such as photodynamic therapy, radiofrequency ablation, cryotherapy, or argon plasma coagulation
  • People with a history of surgical removal of the food pipe due to cancer
  • Women who are pregnant or breastfeeding
  • People who are not able to give their own consent to participate
  • People with unexplained difficulty swallowing that has not yet been investigated (this may not apply to certain parts of the study — confirm with trial site)
  • People with a history of a condition causing an inflamed food pipe due to a specific immune reaction (eosinophilic esophagitis), or a condition affecting food pipe movement (achalasia)
  • People currently taking blood-thinning medications such as Warfarin or Coumadin (this may not apply to certain parts of the study — confirm with trial site)
  • People taking certain anti-clotting medications such as Clopidogrel, unless that medication has been stopped for three to five days before the sponge procedure
  • People taking certain other blood-thinning medications (including Dabigatran, rivaroxaban, apixaban, or edoxaban), unless stopped for three to five days before the sponge procedure
  • People with a history of enlarged veins in the food pipe or stomach (varices) or liver cirrhosis
  • People with inherited or acquired conditions that affect normal blood clotting
  • People with a history of pre-cancerous cell changes in the food pipe (squamous dysplasia)
  • People diagnosed with certain cancers of the digestive system (including pancreatic, bile duct, stomach, or duodenal cancer) within the 5 years before joining the study
  • People who have previously received chemotherapy or radiation therapy to treat cancer of the food pipe or the chest area

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 28 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: Prasad G. Iyer, M.D., Mayo Clinic

Phone: 855-776-0015

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
Registry
ClinicalTrials.gov
Start date
1 July 2021
Est. completion
30 July 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Aim 1 - Screening Population; Aim 2 - Case/Control Population BE Detection; Aim 3 - Dysplasia Detection Sensitivity and Specificity

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: 28 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