Actively Recruiting

Age: 18Years - 90Years
All Genders
NCT04646083

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Texas Tech University Health Science Center El Paso

El Paso, Texas, United States, 79905

Actively Recruiting

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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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Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon | DecenTrialz