Actively Recruiting
Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon
Led by Texas Tech University Health Sciences Center, El Paso · Updated on 2025-06-18
100
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Diagnostic modalities for the evaluation of small bowel pathology include video capsule endoscopy (VCE), antegrade and retrograde device-assisted enteroscopy, CT and MR enterography (1). Despite VCE being the first-line evaluation modality, it lacks interventional capability. Deep enteroscopy (DE) allows tissue sampling and other therapeutic interventions with real-time endoscopic assessment. DE is usually performed with specific endoscopes (balloon-assisted device or spiral overtube) making it time consuming and there is limited availability since special instruments and accessories are required.(1,2) The through-the-scope (TTS) balloon system consists of a balloon catheter designed for anchoring in the small bowel, inserted through the instrument channel of a standard colonoscope.(3) The catheter is advanced, the balloon is inflated and anchored in the small intestine and the endoscope slides over the guiding catheter to the inflated balloon. The most common indications for DE are obscure GI bleeding, iron deficiency anemia, abnormal capsule endoscopy and chronic diarrhea. As compared to spiral, single-or double-balloon enteroscopy, TTS (NaviAid, SMART Medical Systems Ltd, Ra'anana, Israel) is a simpler technique, which requires less investment in infrastructure. The balloon catheter is advanced blindly in front of a standard adult colonoscope as it bends around the curves of the small bowel. To prevent perforation/trauma the catheter is fitted with a soft silicone tip which easily bends under pressure. Insertion depth can be calculated during the withdrawal of the enteroscope. The Aim of the study: To compare the depth of maximal ileal insertion between through-the-scope balloon enteroscopy (NaviAid) with enteroscopy using the adult colonoscope (Olympus CF-190) alone, in the same patient, in a prospective cohort at University Medical Center of El Paso, Texas.
CONDITIONS
Official 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, iron deficiency anemia, or abnormal CT
- Hemodynamically stable patient
You will not qualify if you...
- Unable to sign informed consent form
- Pregnancy or breastfeeding
- Prior colon resection
- Known intestinal strictures
- Altered intestinal anatomy
- Inadequate bowel preparation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
N
Nancy A Casner, BS
CONTACT
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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