Evaluating a new device for treating esophageal achalasia
Safety and Efficacy of the Novel Speedboat UltraSlim With Radiofrequency and Microwave Ablation Flexible Biplolar for Per-Oral Endoscopic Myotomy in Patients With Achalasia: A Single Center Prospective Study
This study is testing a new device called the Speedboat Ultraslim during a procedure for people with esophageal achalasia to see if it can make the treatment safer and help them heal better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Instituto Ecuatoriano de Enfermedades Digestivas Academic / other |
| Locations | 1 site (Guayaquil, Guayas) |
| Trial ID | NCT06264466 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of the Speedboat Ultraslim, a novel flexible bipolar device, during the per-oral endoscopic myotomy (POEM) procedure for patients with esophageal achalasia. The study aims to streamline the POEM process by using a single device that integrates both bipolar radiofrequency and microwave technologies for cutting and coagulation. By minimizing the need for multiple tools, the trial seeks to reduce inflammation and improve healing outcomes. Patients will undergo the POEM procedure with or without fundoplication, performed by trained endoscopists at a single center.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of achalasia who are indicated for POEM.
Not a fit: Patients with contraindications for esophagogastroduodenoscopy, low Eckardt scores, or certain esophageal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced complications for patients undergoing treatment for achalasia.
How similar studies have performed: While the use of novel devices in POEM is an emerging field, similar studies have shown promise in improving procedural outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guayaquil, Guayas
- Instituto Ecuatoriano de Enfermedades Digestivas (IECED) — Guayaquil, Guayas, Ecuador (Recruiting)
Study contacts
- Principal investigator: Carlos Robles-Medranda, MD FASGE — Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
- Study coordinator: Carlos Robles-Medranda, MD FASGE
- Email: carlosoakm@yahoo.es
- Phone: +593989158865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.