Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon (NaviAid2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia, Iron Deficiency; Obscure Gastrointestinal Bleeding

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marc J Zuckerman, MD; Phone Number: 9156306163 9156306163; Email: marc.zuckerman@ttuhsc.edu
• Study Contact Backup: Name: Nancy A Casner, BS; Phone Number: 915-215-5170; Email: Nancy.Casner@ttuhsc.edu

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Recruiting
      • Texas Tech University Health Science Center El Paso
      • Contact: Nancy Casner, MS; Phone Number: 915-215-5170; Email: nancy.casner@ttuhsc.edu
      • Principal Investigator: Marc Zuckerman, MD
      • Sub-Investigator: Luis Chavez, MD
      • Sub-Investigator: Sherif Elhanafi, MD
      • Contact: Marc Zuckerman, MD; Phone Number: (915) 630-6163; Email: marc.zuckerman@ttuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for evaluation of obscure gastrointestinal bleeding with nondiagnostic upper and lower endoscopy with suspicion of distal small bowel source based on either abnormal videocapsule endoscopy or imaging study

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depth of maximal insertion into ileum	depth of insertion is measured on withdrawal of colonoscope by estimating in 10 cm intervals	during the enteroscopy of the patient, about one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic yield of retrograde enteroscopy	proportion of studies with significant findings on enterosocpy	during the enteroscopy of the patient, bout one hour

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Principal Investigator: Marc J Zuckerman, MD, Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: retrograde enteroscopy; small bowel bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Iron Deficiencies; Anemia, Iron-Deficiency; Gastrointestinal Hemorrhage
• Other Study ID Numbers: E20147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No