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New treatment option for Barrett Esophagus
Official title Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
ClinicalTrials.gov ID: NCT03961945
What this study is testing
- What it's testing
- This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90. Healthy volunteers may be eligible.
You may be able to join if
- Aim1:
- Male and female ages 50-85
- Patients who have three or more risk factors for Barrett's Esophagus.
- Gastroesophageal reflux disease defined by:
- Diagnosis
You likely can't join if
- Aim1 and Aim 3:
- Previous history of:
- esophageal adenocarcinoma/cancer
- esophageal squamous carcinoma
- endoscopic ablation for Barrett's esophagus
- esophageal squamous dysplasia
See the full eligibility criteria
- Aim1:
- Male and female ages 50-85
- Patients who have three or more risk factors for Barrett's Esophagus.
- Gastroesophageal reflux disease defined by:
- Diagnosis
- Use of one of the following drugs \>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
- prior endoscopic diagnosis of erosive esophagitis
- Body mass index (BMI) \>= 30
- Aim1 and Aim 3:
- Previous history of:
- esophageal adenocarcinoma/cancer
- esophageal squamous carcinoma
- endoscopic ablation for Barrett's esophagus
- esophageal squamous dysplasia
- Current treatment with oral anticoagulation including Warfarin, Coumadin
- History of cirrhosis
- History of esophageal/gastric varices
- History of Barrett's esophagus
- Prior endoscopy in the last 5 years Inclusion criteria Aim 2 and Aim 3:
- people with known or suspected BE (cases).
- Patient between the ages 18 - 90.
- Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
- Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
- Undergoing clinically indicated endoscopy.
- people without known history of BE (controls).
- Undergoing clinically indicated diagnostic endoscopy. Exclusion criteria Aim 2:
- people with known BE.
- Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal...
- Patients with history of esophageal resection for esophageal carcinoma.
- For people with or without known evidence of BE (on history or review of medical records):
- Pregnant or lactating females.
- Patients who are unable to consent.
- Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
- History of eosinophilic esophagitis, achalasia.
- Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
- Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
- Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.
- Patients with history of known esophageal or gastric varices or cirrhosis.
- Patients with history of surgical esophageal resection for esophageal carcinoma.
- Patients with congenital or acquired bleeding diatheses.
- Patients with a history of esophageal squamous dysplasia.
- Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
- Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Austin, Minnesota, United States
- Mankato, Minnesota, United States
- Rochester, Minnesota, United States
- New Hyde Park, New York, United States
- Dallas, Texas, United States
- Eau Claire, Wisconsin, United States
- La Crosse, Wisconsin, United States
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 to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Austin, Minnesota, United States; Mankato, Minnesota, United States; Rochester, Minnesota, United States; New Hyde Park, New York, United States and 3 more location(s). 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.