Actively Recruiting
Depth of Maximal Insertion During Retrograde Enteroscopy Using Colonoscopy With Through-the-scope Balloon Enteroscopy (NaviAid) Compared With Using the Standard Colonoscope Alone
Led by Texas Tech University Health Sciences Center, El Paso · Updated on 2025-06-18
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the depth of maximal ileal insertion during retrograde enteroscopy in patients who require this procedure for conditions such as obscure gastrointestinal bleeding or iron deficiency anemia. It compares a newer method called through-the-scope (TTS) balloon enteroscopy (NaviAid), which uses a balloon catheter through a standard adult colonoscope, with the traditional use of the colonoscope alone. The study investigates whether the NaviAid system allows deeper insertion into the ileum, potentially improving diagnostic findings of small bowel abnormalities. The study involves performing retrograde enteroscopy on the same patient using two techniques: the standard adult colonoscope (Olympus CF-190) alone and the colonoscope combined with the NaviAid balloon catheter. The NaviAid catheter is advanced blindly through the colonoscope, inflating a soft silicone balloon to anchor in the small bowel, allowing the scope to slide further into the ileum. This method is simpler and requires less specialized equipment compared to other deep enteroscopy techniques. The depth of insertion is measured during the withdrawal of the scope. Participants will undergo enteroscopy procedures lasting about one hour, during which researchers will assess the maximum depth reached in the ileum and evaluate the diagnostic yield of each technique. The study includes patients aged 18 to 90 years who are hemodynamically stable and require retrograde enteroscopy for clinical indications. Safety, preparation adequacy, and other clinical factors will be monitored. The study is observational and conducted at a medical center, with the goal of understanding if NaviAid improves the depth of ileal insertion compared to the colonoscope alone.
CONDITIONS
Brief Title
Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 90 years
- Retrograde enteroscopy indicated for abnormal video capsule endoscopy, non-diagnostic upper and lower endoscopy, obscure gastrointestinal bleeding, or iron deficiency anemia
- Hemodynamically stable
You will not qualify if you...
- Unable to sign informed consent form
- Pregnant or breastfeeding
- Prior colon resection
- Known strictures
- Altered anatomy
- Inadequate bowel preparation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 1 hour
Participants undergo retrograde enteroscopy to compare the depth of maximal ileal insertion using two different colonoscopy methods in the same session.
1 procedure visit (in-person)
Duration - Up to study completion
Participants are observed for outcomes related to diagnostic yield and any follow-up assessments as part of the study.
Visits as needed depending on clinical care
Trial Site Locations
Total: 1 location
1
Texas Tech University Health Science Center El Paso
El Paso, Texas, United States, 79905
Actively Recruiting
Research Team
M
Marc J Zuckerman, MD
N
Nancy A Casner, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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