ClinicalTrials.gg
RecruitingNCT04646083NaviAid2Updated Jun 18, 2025

Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon

An observational study in Obscure Gastrointestinal Bleeding and Anemia, Iron Deficiency, sponsored by Texas Tech University Health Sciences Center, El Paso. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Texas Tech University Health Sciences Center, El Paso · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2021; still recruiting 5 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 133 studies in Anemia, Iron-Deficiency with a site in United States — 17 open to participants now, 20 under way, 6 of them phase 3. Anemia, Iron-Deficiency · United States.

Planned enrollment
7th of 12
100 · median 110
Started
2021
with 10 others
Observational
12 of 133
1 open now
Primary completion
2025-12
later than 4 of 19 live
Registered
102nd of 133
by date

Among the 133 studies in Anemia, Iron-Deficiency with a site in United States, this one is the 7th largest by planned enrollment of the 12 observational ones that give a count, is one of 11 that started in 2021, is one of 12 observational ones, reaches primary completion later than 4 of the 19 other live ones, and was the 102nd registered.

Anemia, Iron-Deficiency

600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.

Browse Anemia, Iron-Deficiency studies →

Open to participants now

17 of the 133 studies in Anemia, Iron-Deficiency with a site in United States are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 54 Anemia, Iron-Deficiency studies recruiting now, 19 (35%) set no upper age limit and 31 (57%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Obscure Gastrointestinal Bleeding
  • Anemia, Iron Deficiency

Keywords

  • retrograde enteroscopy
  • small bowel bleeding
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Sign 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

Exclusion Criteria:

  1. Inability to sign Form
  2. Pregnancy and breast feeding
  3. Prior colon resection
  4. Patients with known strictures
  5. Patients with altered anatomy
  6. Inadequate bowel preparation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. depth of maximal insertion into ileum

    depth of insertion is measured on withdrawal of colonoscope by estimating in 10 cm intervals

    Time frame: during the enteroscopy of the patient, about one hour

Secondary outcomes

  1. diagnostic yield of retrograde enteroscopy

    proportion of studies with significant findings on enterosocpy

    Time frame: during the enteroscopy of the patient, bout one hour

07

Study locations

1 of 1 sites recruiting
  • Texas Tech University Health Science Center El Paso
    El Paso, Texas 79905, United States
    Recruiting
    • Marc Zuckerman, MD · Contactmarc.zuckerman@ttuhsc.edu · (915) 630-6163
    • Nancy Casner, MS · Contactnancy.casner@ttuhsc.edu · 915-215-5170
    • Marc Zuckerman, MD · Principal investigator
    • Luis Chavez, MD · Sub investigator
    • Sherif Elhanafi, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Dec 2025, 59 months after the start.

Of 49 non-industry observational studies under Anemia, Iron-Deficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 59 months is above that.

Counting every sponsor, half of 54 studies reached it within 26 months; a quarter within 11 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2020
First posted
Nov 27, 2020
StartActual
Jan 14, 2021
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Jun 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04646083
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Responsible party
Marc Zuckerman (Professor of Medicine, Texas Tech University Health Sciences Center, El Paso) — Principal investigator
First posted
Nov 27, 2020
Start date
Jan 14, 2021
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 18, 2025

Study contacts

Marc J Zuckerman, MD
Contact
marc.zuckerman@ttuhsc.edu
9156306163 ext. 9156306163
Nancy A Casner, BS
Contact
Nancy.Casner@ttuhsc.edu
915-215-5170
Marc J Zuckerman, MD
principal investigator · Texas Tech University Health Sciences Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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