NCT Number: NCT04646083
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
El Paso, Texas, 79905, United States
Location status: Recruiting
Luis Chavez, MD
SUB_INVESTIGATOR
Marc Zuckerman, MD
CONTACT
Marc Zuckerman, MD
PRINCIPAL_INVESTIGATOR
Nancy Casner, MS
CONTACT
Sherif Elhanafi, MD
SUB_INVESTIGATOR
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 from August 1, 2020 to July 31, 2023 at University Medical Center of El Paso, Texas.
Depth of insertion is correlated with diagnostic yield, meaning that we would like to ascertain if the use of the colonoscope with NaviAid will result in greater depth of insertion and potentially more findings of small bowel abnormalities than using a colonoscope alone.
It is assumed that this is the case, but we want to show it and quantify it.
HYPOTHESIS:
The depth of ileal insertion is greater with the use of through-the-scope balloon enteroscopy (NaviAid) when compared with enteroscopy using the standard adult colonoscope (Olympus CF-190) alone.
OBJECTIVE:
To compare the depth of maximal ileal insertion between through-the-scope balloon enteroscopy (NaviAid) with the adult colonoscope (Olympus CF-190) alone, in the same patient, in a prospective cohort at University Medical Center of El Paso, Texas.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Time frame: during the enteroscopy of the patient, about one hour
depth of insertion is measured on withdrawal of colonoscope by estimating in 10 cm intervals
Time frame: during the enteroscopy of the patient, bout one hour
proportion of studies with significant findings on enterosocpy
Contact information is provided by the study sponsor or research team.
Texas Tech University Health Sciences Center, El Paso
Other
Depth of Maximal Insertion During Retrograde Enteroscopy Using Colonoscopy With Through-the-scope Balloon Enteroscopy (NaviAid) Compared With Using the Standard Colonoscope Alone
Acronym: NaviAid2
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