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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Sign Informed Consent Form

• Patients age between 18-90 years

• 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

Locations
United States
Texas
Texas Tech University Health Science Center El Paso
RECRUITING
El Paso
Contact Information
Primary
Marc J Zuckerman, MD
marc.zuckerman@ttuhsc.edu
9156306163
Backup
Nancy A Casner, BS
Nancy.Casner@ttuhsc.edu
915-215-5170
Time Frame
Start Date: 2021-01-14
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Sponsors
Leads: Texas Tech University Health Sciences Center, El Paso

This content was sourced from clinicaltrials.gov