Clinical trial NCT06264466: Safety and Efficacy of a Novel Flexible Bipolar in POEM
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Achalasia
Keywords: achalasia
POEM
Radiofrequency
microwave
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interventional trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Achalasia is characterized by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax. To date, the therapies with higher success rates are the Heller myotomy and the minimally invasive per-oral endoscopic myotomy (POEM). Different tools have been developed for the different POEM stages (mucosal incision, submucosal tunneling, myotomy, and closure). However, some devices need exchanging accessories for cutting and coagulation.

In light of the above, the investigators aim to evaluate a newly launched ultra-slim flexible catheter, Speedboat Ultraslim (Creo Medical, UK) that integrates bipolar radiofrequency (RFA) energy and microwave in its tip for cutting and coagulation, respectively, in patients with achalasia. Some proposed advantages of using this device during POEM are (1) less inflammation and better healing process derived from localized bipolar energy; (2) a protective full that facilities clear differentiation between muscular and mucosal layers; (3) the use of a single device to complete the POEM procedure.

After completing the inclusion criteria, the patients with achalasia will undergo POEM (anterior or posterior incision) with or without fundoplication (F-POEM). The procedures will be performed by previously trained expert endoscopist. The mucosal incision, submucosal tunneling and cutting will be performed using RFA energy, while coagulation will be performed with microwave, both integrated in the tip of the Ultraslim Speedboat.

Technical and clinical success along with safety will be the primary outcomes; while post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) along with endoscopic and pH studies; and the Northwestern Esophageal Quality of Life (NEQOL), respectively.

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.

Primary outcomes:
measure: Technical success of procedure
timeFrame: up tp four hours
measure: Clinical success of procedure
timeFrame: up to one year
measure: Frequency of adverse events attributable to the procedure
timeFrame: Up to three months
Secondary outcomes:
measure: Rate of Gastroesophageal reflux disease
timeFrame: Up to one year
measure: Assessment of Gastroesophageal reflux disease severity
timeFrame: Up to one year
measure: Change in health-related quality of life after POEM
timeFrame: Up to six months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
state: Guayas
Study officials:
affiliation: Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
name: Carlos Robles-Medranda, MD FASGE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rolland S, Paterson W, Bechara R. Achalasia: Current therapeutic options. Neurogastroenterol Motil. 2023 Jan;35(1):e14459. doi: 10.1111/nmo.14459. Epub 2022 Sep 25.
citation: Tasnim S, Raja S, Sudarshan M. Achalasia: Surgery Versus Per-Oral Endoscopic Myotomy. Thorac Surg Clin. 2023 May;33(2):135-140. doi: 10.1016/j.thorsurg.2023.01.007. Epub 2023 Feb 26.
citation: Patil G, Dalal A, Maydeo AP. Feasibility of Speedboat RS2 with bipolar radiofrequency energy for peroral endoscopic myotomy in patients with achalasia (with video). Endosc Int Open. 2020 Aug;8(8):E998-E1001. doi: 10.1055/a-1165-0087. Epub 2020 Jul 21.