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โ† Trials
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Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM

RecruitingNAAges 18 Years - anyAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

Achalasia is an idiopathic motility disorder, primarily identified by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax properly. Although it is usually misdiagnosed and treated as gastroesophageal reflux disease (GERD), the main symptom is progressive dysphagia, accompanied by additional symptoms like nocturnal cough, heartburn, weight loss, regurgitation of undigested food and aspiration. The severity of achalasia and the effectiveness of treatments are commonly assessed using the Eckardt Symptom Score (ESS), which evaluates symptoms like weight loss, regurgitation, dysphagia, and retrosternal pain. Diagnosis of achalasia is often delayed, affecting up to 50% of patients. It typically involves a combination of diagnostic tools, such as time barium esophagram (TBE) study, which assesses the movement and clearance of barium in the

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients with 18 years of age or older. * Patients referred to the participating center with a clinical indication for POEM. This includes conditions such as: achalasia, native or failed Heller myotomy, balloon dilation, and EGJ outflow obstruction. * Patients who provide informed consent. Exclusion Criteria: * Patients who have contraindications for EGD. * Patients with an Eckardt score \< 3 before POEM. * Positive diagnosis of Chagas disease. * Patients unable to withstand general anesthesia.
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What it tests

  • SpydrBlade Flex
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Where

2 sites
academy tertiary, IECED
Guayaquil, Ecuador
Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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