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Trial record 8 of 1715 for:    "Mayo Clinic" [Exact]

Characterization of the Neo-squamous Epithelial Barrier

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03077594
First received: February 1, 2017
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic therapy for Barrett's Esophagus related metaplasia.

Condition Intervention
Barrett's Esophagus With Dysplasia
Device: Mucosal Impedance
Other: Research Biopsies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mucosal Impedance as measured by an endoscopic probe [ Time Frame: Up to one year ]
    Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.


Secondary Outcome Measures:
  • Tissue levels of prostaglandin E2 [ Time Frame: Up to one year ]
    Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.

  • Intracellular space [ Time Frame: Up to one year ]
    Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.


Estimated Enrollment: 40
Actual Study Start Date: September 26, 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Successfully ablated patients
Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy.
Device: Mucosal Impedance
Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation.
Other: Research Biopsies
Research biopsies will be obtained at 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction, and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation.

Detailed Description:

The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia).

Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Research biopsies will also be obtained at these levels for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (age 18-90) who underwent an ablative program for BE

Exclusion Criteria:

  • Patients that have not achieved complete remission of intestinal metaplasia.
  • Patients unable to consent.
  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03077594

Contacts
Contact: Michele L Johnson, CCRP 507-255-8692 johnson.michele@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson, CCRP    507-255-8692    johnson.michele@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03077594     History of Changes
Other Study ID Numbers: 16-005490
Study First Received: February 1, 2017
Last Updated: March 7, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on March 28, 2017