RECRUITING

Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-14
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04646083

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Sign Informed Consent Form
  2. 2. Patients age between 18-90 years
  3. 3. Patients in which retrograde enteroscopy is indicated for any of the following:
  1. 1. Inability to sign Informed Consent Form
  2. 2. Pregnancy and breast feeding
  3. 3. Prior colon resection
  4. 4. Patients with known strictures
  5. 5. Patients with altered anatomy
  6. 6. Inadequate bowel preparation.

Contacts and Locations

Study Contact

Marc J Zuckerman, MD
CONTACT
9156306163
marc.zuckerman@ttuhsc.edu
Nancy A Casner, BS
CONTACT
915-215-5170
Nancy.Casner@ttuhsc.edu

Principal Investigator

Marc J Zuckerman, MD
PRINCIPAL_INVESTIGATOR
Texas Tech University Health Sciences Center

Study Locations (Sites)

Texas Tech University Health Science Center El Paso
El Paso, Texas, 79905
United States

Collaborators and Investigators

Sponsor: Texas Tech University Health Sciences Center, El Paso

  • Marc J Zuckerman, MD, PRINCIPAL_INVESTIGATOR, Texas Tech University Health Sciences Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-14
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-01-14
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • retrograde enteroscopy
  • small bowel bleeding

Additional Relevant MeSH Terms

  • Obscure Gastrointestinal Bleeding
  • Anemia, Iron Deficiency