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Depth of Maximal Ileal Insertion During Retrograde Enteroscopy With TTS Balloon

Recruitingn/aAges 18 Years - 90 YearsAllTexas Tech University Health Sciences Center, El …
NCT04646083 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Texas Tech University Health Science Center El Paso
El Paso, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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