Safety and Efficacy of a Novel Flexible Bipolar in POEM

NCT06264466 | Recruiting DMC

• 1 other identifier: IECED-010112023
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Achalasia

Keywords

achalasia; POEM; Radiofrequency; microwave

Outcome Measures

Primary Outcomes (3)

• Technical success of procedure

  Successful competition of all the stages of the POEM procedure with passage of endoscope through the EGJ.

  up tp four hours

• Clinical success of procedure

  The clinical success of the POEM procedure will be assessed by using the Eckardt score. An Eckardt score of ≤3 will be considered as clinical success.

  up to one year

• Frequency of adverse events attributable to the procedure

  Frequency of adverse events attributable to the procedure, based on American Society of Gastrointestinal Endoscopy (ASGE) lexicon.

  Up to three months

Secondary Outcomes (3)

• Rate of Gastroesophageal reflux disease

  Up to one year

• Assessment of Gastroesophageal reflux disease severity

  Up to one year

• Change in health-related quality of life after POEM

  Up to six months

Study Arms (1)

POEM with Speedboat Ultraslim

EXPERIMENTAL

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

Device: POEM with Speedboat Ultraslim

Interventions

POEM with Speedboat Ultraslim DEVICE

POEM procedures, with or without fundoplication, will be conducted by expert endoscopists who have undergone prior training in the utilization of the ultraslim Speedboat. Incisions, whether anterior or posterior, submucosal tunneling, and myotomy will be performed using the Bipolar Radiofrequency Ablation (RFA) integrated into the device's tip. Additionally, for vessel coagulation, the microwave energy integrated into the device's tip will be employed. Successful myotomy will be confirmed by passage of the endoscope through the esophagogastric junction (EGJ) without restriction.

POEM with Speedboat Ultraslim

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Guayaquil, Guayas, 090505, Ecuador

RECRUITING

Related Publications (3)

• 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.

  PMID: 36153803 BACKGROUND

• 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.

  PMID: 37045482 BACKGROUND

• 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.

  PMID: 32743048 BACKGROUND

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Carlos Robles-Medranda, MD FASGE

  Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Robles-Medranda, MD FASGE

CONTACT

+593989158865; carlosoakm@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional trial

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 15, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

EC (1)