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Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04646083
Acronym
NaviAid2
Enrollment
100
Registered
2020-11-27
Start date
2021-01-14
Completion date
2025-12-31
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron Deficiency, Obscure Gastrointestinal Bleeding

Keywords

retrograde enteroscopy, small bowel bleeding

Brief 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.

Detailed description

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.

Interventions

None listed

Sponsors

Texas Tech University Health Sciences Center, El Paso
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
depth of maximal insertion into ileumduring the enteroscopy of the patient, about one hourdepth of insertion is measured on withdrawal of colonoscope by estimating in 10 cm intervals

Secondary

MeasureTime frameDescription
diagnostic yield of retrograde enteroscopyduring the enteroscopy of the patient, bout one hourproportion of studies with significant findings on enterosocpy

Countries

United States

Contacts

Primary ContactMarc J Zuckerman, MD
marc.zuckerman@ttuhsc.edu9156306163
Backup ContactNancy A Casner, BS
Nancy.Casner@ttuhsc.edu915-215-5170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026