Comparing Depth of Insertion in Retrograde Enteroscopy Using NaviAid Balloon System Versus Standard Colonoscope Alone

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.

Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon