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

Depth of Maximal Insertion During Retrograde Enteroscopy Using Colonoscopy With Through-the-scope Balloon Enteroscopy (NaviAid) Compared With Using the Standard Colonoscope Alone

This study is testing whether a special balloon system can help doctors see deeper into the small intestine compared to a regular colonoscope for patients needing enteroscopy.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Texas Tech University Health Sciences Center, El Paso (other)
• Locations: 1 site (El Paso, Texas)
• Trial ID: NCT04646083 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-90 who require retrograde enteroscopy for specific gastrointestinal issues.

Not a fit: Patients who may not benefit include those with prior colon resection, known strictures, altered anatomy, or inadequate bowel preparation.

Why it matters

Potential benefit: If successful, this study could enhance diagnostic capabilities for patients with obscure gastrointestinal bleeding and related conditions.

How similar studies have performed: While the approach of using a through-the-scope balloon system is innovative, similar studies have shown promising results in enhancing diagnostic yield in gastrointestinal procedures.

Eligibility criteria

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 this trial is running

El Paso, Texas

• 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

Conditions: Obscure Gastrointestinal Bleeding, Anemia, Iron Deficiency, retrograde enteroscopy, small bowel bleeding