Status:
NOT_YET_RECRUITING
Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Inflammatory Bowel Disease (IBD)
Colonoscopy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In this study, the investigators will test the ability of the Magnetic Flexible Endoscope (MFE) to travel through the colon of people with Inflammatory Bowel Disease (IBD). The MFE is a device made of...
Detailed Description
Colonoscopy is the gold standard for making the diagnosis, following clinical response, establishing prognosis, and creation of management plans for patients with Inflammatory Bowel Disease (IBD). Whi...
Eligibility Criteria
Inclusion
- Male or female, 18 to 70 years of age
- Able to provide written informed consent
- American Society of Anesthesiologists (ASA) class \< 3
- No significant medical problems
- Abdominal circumference \< 96 cm
- Stable, non-flaring inflammatory bowel disease (e.g. Ulcerative Colitis and Crohn's Disease)
Exclusion
- Patients who do not meet inclusion criteria
- Patients who are unable or unwilling to provide informed consent
- Magnetic implants and wearable devices (such as insulin pumps)
- Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.
- Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.
- Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough, or anosmia --- or a positive coronavirus (COVID-19) polymerase chain reaction (PCR) swab result
- Previous incomplete or failed colonoscopy
- Colonic resection
- Severe diverticulosis
- Known or suspected colonic stricture
- Previous radiation therapy to the abdomen or pelvis
- Actively flaring inflammatory bowel condition (e.g. active flare of IBD or diverticulitis)
- Known or suspected bowel obstruction
- Presence of ascites
- Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 3 days
- Known coagulation disorder (INR ≥ 1.5 or platelets \< 150 x 109)
- Known to have phenylketonuria or Glucose-6-Phosphate-Dehydrogenase (G6PD) deficiency
- Abdominal surgery within the last 6 months
- Drug or alcohol abuse
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06989424
Start Date
February 1 2026
End Date
June 1 2026
Last Update
September 25 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232