Comparing ileal insertion depth using a special balloon system versus a standard colonoscope

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the depth of maximal ileal insertion achieved with a through-the-scope balloon enteroscopy system (NaviAid) against a standard adult colonoscope (Olympus CF-190) in patients requiring retrograde enteroscopy. Conducted at the University Medical Center of El Paso, Texas, the study will assess whether the use of the NaviAid system results in greater insertion depth and improved diagnostic yield for small bowel abnormalities. The study will involve a prospective cohort of patients from August 2020 to July 2023, with each patient serving as their own control. The hypothesis is that the NaviAid system will facilitate deeper insertion compared to the standard colonoscope alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Sign Informed Consent Form
2. Patients age between 18-90 years
3. Patients in which retrograde enteroscopy is indicated for any of the following:

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:

1. Inability to sign Informed Consent Form
2. Pregnancy and breast feeding
3. Prior colon resection
4. Patients with known strictures
5. Patients with altered anatomy
6. Inadequate bowel preparation.

Where it's running

• Texas Tech University Health Science Center El Paso
  El Paso, Texas, United States Recruiting

Study contacts

• Principal investigator: Marc J Zuckerman, MD — Texas Tech University Health Sciences Center
• Study coordinator: Marc J Zuckerman, MD
• Email: marc.zuckerman@ttuhsc.edu
• Phone: 9156306163

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.