Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon

NCT04646083 | Recruiting

• 1 other identifier: E20147
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obscure Gastrointestinal Bleeding; Anemia, Iron Deficiency

Keywords

retrograde enteroscopy; small bowel bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• diagnostic yield of retrograde enteroscopy

  during the enteroscopy of the patient, bout one hour

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Inability to sign Informed Consent Form
• Pregnancy and breast feeding
• Prior colon resection
• Patients with known strictures
• Patients with altered anatomy
• Inadequate bowel preparation.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Science Center El Paso

El Paso, Texas, 79905, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marc J Zuckerman, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc J Zuckerman, MD

CONTACT

9156306163; marc.zuckerman@ttuhsc.edu

Nancy A Casner, BS

CONTACT

915-215-5170; Nancy.Casner@ttuhsc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: January 14, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)