G.I. Research

Advanced Gastroenterology Associates, LLC, conducts research in selected areas of concern to our patients. Our team participates in research for 2 reasons:

  1. To stay ahead of the latest G.I. treatments by participating in the development and delivery of care. We estimate that we can be 5 years ahead of current methods.
  2. Provide a way to help less fortunate patients who may not be able to afford state of the art G.I. medical treatments.

We conduct our research studies at our Palm Harbor facility. Volunteering to be in a research trial will assist in the development of new medical therapies that may offer better treatments and even cures for life threatening and chronic diseases. Our research trials are regulated by the federal governement and also reviewed by independent ethics committees.

To be considered as a participant into a research study, a signed Informed Consent must be obtained prior to any study related procedures being completed. An Informed Consent will help a study participant understand the purpose, procedures, potential risks and benefits of their involvement, along with alternative treatment if applicable. Participating in a research study is voluntary.

Key points about our research:

  • Insurance is not necessary.
  • Study volunteers may be compensated for time and travel.
  • Study availability changes frequently so please contact our research office for updated status about enrolling trials.
  • Trials open and close at a rapid pace.
  • We will continue to update our research page to keep our patients up to date on the newest research trials.
Joanne Root

Site Director/CCRC

Joanne Root

Katrina Ostrovsky

Clinical Research Coordinator

Katrina Ostrovsky

34041 US Highway 19 North, Suite A
Palm Harbor, FL 34685
Direct Phone ~ 727-216-0768
Fax ~ 727-786-7521

Email ~ research@advancedgastro.com

Please contact us in our Palm Harbor office or complete the Research Contact Form.

Note: Be sure to download and complete the New Patient Forms before your visit.

Biorepository research projects
If you are a current or new patient you may qualify for one of the following:

Biospecimens (primarily blood donation, and could also include hair, nail, skin, urine, stool samples, dependent on project) will be collected from donors, along with a collection of limited information related to the specimen and health status of donor. No testing results will be available for your donation, with no direct benefit to donor, aside from contributing to the area of future research.

Patients like you are at the core of biomedical research. Contributions of biospecimens —blood and other biofluids, tissue, and cells—fuel medical discovery, leading to new diagnostics and therapies with the potential to benefit millions of patients worldwide.

Some examples of our projects under way are:

  • Healthy non-smokers – specimen donation used for future research in Lung diseases
  • Individuals scheduled for a colonoscopy – specimen donation used for future research for colorectal cancer
  • Fatty Liver – specimen donation used for future research for Liver diseases

Call our office to see if you qualify for one of our studies.

Seeking Men, Age 50 and Over,
With Heartburn symptoms for at least 5 years

  • Are you Male and at least 50 years of age?
  • Have you had recurrence of heartburn symptoms for at least 5 years?
  • If you have never had an upper endoscopy to evaluate your symptoms, and are planning to schedule your first one?

If so, you may be eligible to participate in the Lucid EsoCheck study. All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies).

The EsoCheck a device that collects cells from the esophagus in a five-minute procedure, without the need for endoscopy, for the diagnosis of Barrett’s Esophagitis and related conditions.

Required Inclusion Criteria
  1. Men aged 50 years old and older
  2. 5 years either of
    • GERD symptoms,
    • GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or,
    • any combination of treated and untreated periods, as long the cumulative total is at least 5 years
  3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
  4. One or more of the following risk factors:

    a. Caucasian race
    b. Current or past history of cigarette smoking
    c. BMI of at least 30 kg/m2
    d. First-degree relative with Barrett’s Esophagitis or Esophageal Cancer

Exclusion Criteria that will prohibit candidates from entering trial:
  1. History of prior EGD procedure
  2. Inability to provide written informed consent
  3. On anti-coagulant drug(s) that cannot be temporarily discontinued
  4. Known history of esophageal varices or esophageal stricture
  5. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
  6. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
  7. Oropharyngeal tumor
  8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
  9. History of myocardial infarction or cerebrovascular accident within past 6 months
  10. History of esophageal motility disorder
  11. Currently implanted Linx device
If you qualify you will receive the Lucid EsoCheck procedure, and compensation for your time and travel.
It is important to know that the trial does not cover the costs of the Endoscopy, which will need to be performed by one of our physicians and will be the responsibility of the patient or their insurance company.

The following link will show you the process of this simplistic, non-evasive procedure:  https://www.youtube.com/watch?v=iiv0Gws4sdA

This trial can be further reviewed on www.clinicaltrials.gov under the following link:  https://clinicaltrials.gov/ct2/show/NCT04293458

Other important readings:  https://www.globenewswire.com/news-release/2020/04/02/2010842/0/en/PAVmed-Subsidiary-Lucid-Diagnostics-EsoCheck-Esophageal-Cell-Collection-Device-Receives-Prestigious-Edison-Best-New-Product-Award.html

Observational 5-yr registry for those with recent diagnosis of Fatty Liver/NASH
  • Must be followed as part of Standard of Care with one of our physicians AT LEAST ONCE A YEAR

Observational 5-yr registry for those with Ulcerative Colitis or Crohn's Disease
  • Must be under current treatment and being followed as part of Standard of Care with one of our physicians

Gastroesophageal Reflux Study

Must have reported heartburn symptoms for at least 5 years and agree to have an upper endoscopy completed.

Estimated Study Duration:

The total duration of the study may last up to 4 months.

Qualified study participants may receive the following:

  • Study-related health assessments such as physicals, lab work, ECG's, off site Endoscopy
  • Study related treatmemnt
  • Reimbursement for your time and travel

One time Blood Specimen study for those diagnosed with Non-Viral Liver Disease

Subjects must not have been diagnosed with Viral Hepatitis (A, B, C, D, E) or HIV

  • Alcoholic Hepatitis
  • Autoimmune Hepatitis
  • Cholangiocarcinoma
  • Cirrhosis
  • Granulomatous Hepatitis
  • Hepatocellular Carcinoma
  • NASH
  • Obstructive Jaundice
  • Wilson's Disease

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