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NCT04646083 · ClinicalTrials.gov registry record
Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon
A clinical trial of Anemia, Iron Deficiency and Obscure Gastrointestinal Bleeding, sponsored by Texas Tech University Health Sciences Center, El Paso.
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT04646083 is a study of Anemia, Iron Deficiency and Obscure Gastrointestinal Bleeding that is actively recruiting participants, run by Texas Tech University Health Sciences Center, El Paso. The registered enrollment target is 100 participants, below the 178-participant average among 8 other Anemia, Iron Deficiency trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04646083, a study of Anemia, Iron Deficiency and Obscure Gastrointestinal Bleeding, is actively recruiting participants, sponsored by Texas Tech University Health Sciences Center, El Paso.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Study Locations (1)
Texas
- Texas Tech University Health Science Center El Paso - El Paso
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2025-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04646083
The ClinicalTrials.gov registry entry for NCT04646083 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 8 other Anemia, Iron Deficiency trials with a reported enrollment target (44% lower). The listed sponsor is Texas Tech University Health Sciences Center, El Paso, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Anemia, Iron Deficiency appearing as the primary indexed condition, and to 0 interventions.
NCT04646083 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04646083 about?
NCT04646083 is a clinical study titled "Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon". 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) a...
What is the current status of trial NCT04646083?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2021-01-14. Estimated completion is 2025-12-31.
What conditions does trial NCT04646083 study?
This clinical trial studies the following conditions: Anemia, Iron Deficiency, Obscure Gastrointestinal Bleeding.
Who is sponsoring clinical trial NCT04646083?
This trial is sponsored by Texas Tech University Health Sciences Center, El Paso, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04646083 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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