Recruiting

Observational Study

Sponsor:

Texas Tech University Health Sciences Center, El Paso

Code:

NCT04646083

Conditions

Obscure Gastrointestinal Bleeding

Anemia, Iron Deficiency

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04646083

Start date

Jan 14, 2021

Status verified date

Jun, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • depth of maximal insertion into ileum [ Time Frame: during the enteroscopy of the patient, about one hour ]

Central Contacts and Locations

Central contacts

Locations

Texas Tech University Health Science Center El Paso

Recruiting

El Paso, Texas, United States, 79905

Contacts

Principal Investigator:

Marc Zuckerman, MD

More Information

Sponsor

Texas Tech University Health Sciences Center, El Paso

Last update posted

Jun 18, 2025

Last verified

Jun, 2025

Keywords

  • retrograde enteroscopy
  • small bowel bleeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center, El Paso on 2025-06-18.