NL-OMON43360CompletedPhase 3
PROGRESSIVE ESOPHAGEAL DILATION FOR BENIGN STRICTURES: A RANDOMIZED CONTROLLED TRIAL - PROGRESSIVE ESOPHAGEAL DILATION FOR BENIGN STRICTURES
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Dysphagia due benign esophageal stricture requiring esophageal dilation (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy)
- •- Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter)
- •- No history of esophageal endoscopic dilations for benign strictures the past 6 months
- •- Dysphagia for solid, semisolid or liquid food (dysphagia score <= 2 [Ogilvie]16, and dysphagia score <= 21 [Dakkak and Bennett]19, see appendix)
- •- Written informed consent
Exclusion Criteria
- •- Patient < 18 years old
- •- Patient is unwilling or unable to sign and date the informed consent
- •- Patient is unwilling or unable to comply with the follow-up schedule
- •- Patient is unable to understand informed consent and fill in the questionnaires due to a language barrier
- •- Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month
- •- Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
- •- Previous esophageal dilation for benign stricture within the past 6 months
- •- Patient with a life expectancy < 12 months
- •- Patient with a known eosinophilic esophagitis or motility disorder (such as achalasia)
- •- Patients with a known malignant esophageal stricture
- •- Patients with coagulopathy
- •- Patients with a benign stricture due to a previous performed laryngectomy
Investigators
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