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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM. To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure. This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ecuador
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
RECRUITING
Guayaquil
Contact Information
Primary
Carlos Robles-Medranda, MD FASGE
carlosoakm@yahoo.es
+593989158865
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-01-15
Participants
Target number of participants: 73
Treatments
Experimental: POEM with Speedboat Ultraslim
Participants aged 18-years and above, referred to the participating center (IECED) with a diagnosis of achalasia and indication for POEM, POEM procedures will be performed using the Speedboat UltraSlim
Related Therapeutic Areas
Sponsors
Leads: Instituto Ecuatoriano de Enfermedades Digestivas

This content was sourced from clinicaltrials.gov