Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon (NaviAid2)

STUDY OVERVIEW

This study aims to compare the depth of ileal insertion achieved with through-the-scope balloon enteroscopy (NaviAid) versus using the adult colonoscope (Olympus CF-190) alone in the same patient cohort at the University Medical Center of El Paso, Texas, from August 1, 2020, to July 31, 2023. Greater insertion depth is associated with higher diagnostic yield, potentially leading to more findings of small bowel abnormalities. The hypothesis is that NaviAid will achieve greater depth of insertion compared to the standard colonoscope alone, with the objective of quantifying and demonstrating this difference.

STUDY GOALS

The study aims to compare the depth of maximal ileal insertion between through-the-scope balloon enteroscopy (NaviAid) and enteroscopy using the adult colonoscope (Olympus CF-190) alone, in the same patient cohort, to determine if NaviAid achieves greater insertion depth, potentially leading to higher diagnostic yield of small bowel abnormalities.

LOCATION

El Paso, Texas: Texas Tech Health Sciences Center at El Paso

INCLUSION CRITERIA

  • Signed Informed Consent Form

  • Patients aged 18-90 years

  • Indicated for retrograde enteroscopy due to:

    • Abnormal video capsule endoscopy

    • Non-diagnostic upper and lower endoscopy

    • Obscure gastrointestinal bleeding

    • Iron deficiency anemia

    • Non-diagnostic upper endoscopy and abnormal CT

  • Hemodynamically stable

exclusion criteria

  • Unable to sign Informed Consent Form

  • Pregnancy or breastfeeding

  • Prior colon resection

  • Known strictures

  • Altered anatomy

  • Inadequate bowel preparation.

Study Population: Patients referred for evaluation of obscure gastrointestinal bleeding with nondiagnostic upper and lower endoscopy with suspicion of distal small bowel source based on either abnormal videocapsule endoscopy or imaging study

For more information, visit ClinicalTrials.gov.