Assessment of Colonic Epithelial Integrity With Mucosal Impedance

NCT03165058 | Completed Results

• 1 other identifier: 160534
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity changes in the colonic epithelium.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Mucosal Impedance Values

  compare the mucosal impedance values between subjects with IBD and controls

  15 minutes

Secondary Outcomes (1)

• Difference in Inflamed and Normal Mucosa

  15 minutes

Study Arms (2)

Inflammatory Bowel Disease

Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.

Diagnostic Test: mucosal impedance (MI) testing

control

Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.

Diagnostic Test: mucosal impedance (MI) testing

Interventions

mucosal impedance (MI) testing DIAGNOSTIC_TEST

During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.

Inflammatory Bowel Disease; control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified by physicians in the endoscopy center at Vanderbilt. Those patients undergoing colonoscopy for either the indication of screening colonoscopy or IBD surveillance will be asked, on the day of their colonoscopy, whether they want to participate in the study.

You may qualify if:

• Men and women over the age of 18 with a diagnosis of IBD (Ulcerative Colitis or Crohn's Disease)
• Men and women undergoing screening colonoscopy (typical age would be 50 or greater but there are exceptions)

You may not qualify if:

• Age less than 18 years old
• Patients unable to give informed consent
• Patients with history of colonic surgeries
• Patients with history of colonic motility disorder

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center Endoscopy Laboratory

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Tina Higginbotham
• Organization: GI Clinical Research Enterprise

tina.higginbotham@vumc.org

615-322-4643

Study Officials

• Yash Choksi, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: November 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 7, 2021
• Results First Posted: June 5, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)