Safety and Efficacy of a Novel Flexible Bipolar in POEM

Launched by INSTITUTO ECUATORIANO DE ENFERMEDADES DIGESTIVAS · Feb 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Speedboat Ultraslim, which is designed to improve a procedure known as per-oral endoscopic myotomy (POEM) for treating esophageal achalasia. Achalasia is a condition that makes it difficult for food to pass from the esophagus to the stomach. The Speedboat device combines two functions—cutting and coagulating tissue—into one tool, which may make the procedure more efficient and reduce inflammation. The trial will assess how well this device works, its safety, and how it affects patients' quality of life after the procedure.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with achalasia that requires treatment with POEM. This includes those who have not had success with other treatments. Participants will be treated at a specific center and will need to give their informed consent to join the trial. Throughout the study, researchers will monitor the success of the procedure and any side effects, along with how patients feel afterward regarding symptoms like acid reflux. If you or someone you know is considering this treatment, participating in this trial could provide access to a potentially beneficial new technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with 18 years of age or older.
• • Patients referred to the participating center (IECED) with a clinical diagnosis of achalasia with an indication for POEM, including previously failed Heller myotomy, balloon dilation or POEM
• • Patients who provide informed consent.
• Exclusion Criteria:
• • Patients who have contraindications for esophagogastroduodenoscopy (EGD).
• • Patients with an Eckardt score \< 3 before POEM.
• • Positive diagnosis of Chagas disease.
• • Patients unable to withstand general anesthesia.
• • Pregnancy and lactation.
• • Barret's esophagus.