Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM

February 6, 2026 updated by: Hon Chi Yip, Chinese University of Hong Kong

Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Per-Oral Endoscopic Myotomy in Patients With Achalasia: A Multicenter Prospective Study

Achalasia is an idiopathic motility disorder, primarily identified by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax properly. Although it is usually misdiagnosed and treated as gastroesophageal reflux disease (GERD), the main symptom is progressive dysphagia, accompanied by additional symptoms like nocturnal cough, heartburn, weight loss, regurgitation of undigested food and aspiration.

The severity of achalasia and the effectiveness of treatments are commonly assessed using the Eckardt Symptom Score (ESS), which evaluates symptoms like weight loss, regurgitation, dysphagia, and retrosternal pain.

Diagnosis of achalasia is often delayed, affecting up to 50% of patients. It typically involves a combination of diagnostic tools, such as time barium esophagram (TBE) study, which assesses the movement and clearance of barium in the esophagus; esophagogastroduodenoscopy (EGD), which allows visual examination of the esophagus, stomach, and duodenum; and high-resolution esophageal manometry (HREM), considered the gold standard for achalasia. HREM can also help stratify the condition into different types, influencing treatment choices. Furthermore, the endoluminal functional lumen imaging probe (Endoflip, Crospon Corp, Dangan Galaway, Ireland), which measures baseline parameters of LES, aiding in both diagnosis and treatment evolution.

While there is no cure for achalasia, treatments aim to reduce LES pressure. The include pharmacological treatments, such as calcium channel blockers or nitrates; endoscopic treatment, including injection of botulinum toxin in the LES, pneumatic dilation, or per-oral endoscopic myotomy (POEM); and surgical therapies (laparoscopic Heller myotomy). POEM has emerged as a first-line treatment for achalasia due to its minimally invasive nature and high success rates (80%-90%). This technique involves creating a submucosal tunnel and performing myotomy, and it can be performed anteriorly (at 2 o'clock) or posteriorly (at 5 o'clock).

The choice between anterior and posterior approaches to POEM often depends on the endoscopist's experience and preference. While current data is inconclusive regarding the superiority of either approach, some suggest that the posterior approach might be technically easier due to procedural characteristics (i.e., alignment between endoscopic accessories and mucosal incision). The introduction to novel technologies with smaller diameters can improve this minimally invasive approach making the procedure more efficient and safer for patients with achalasia. Thus, we aim to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for per-oral endoscopic myotomy in patients with achalasia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ecuador
      • Guayaquil, Ecuador
        • Recruiting
        • academy tertiary, IECED
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with 18 years of age or older.
  • Patients referred to the participating center with a clinical indication for POEM. This includes conditions such as: achalasia, native or failed Heller myotomy, balloon dilation, and EGJ outflow obstruction.
  • Patients who provide informed consent.

Exclusion Criteria:

  • Patients who have contraindications for EGD.
  • Patients with an Eckardt score < 3 before POEM.
  • Positive diagnosis of Chagas disease.
  • Patients unable to withstand general anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SpydrBlade Flex Group
Patients will undergo Per-Oral Endoscopic Myotomy (POEM) using the novel SpydrBlade Flex device.
Device: SpydrBlade Flex
The POEM procedure will be performed using the novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK). Both anterior and posterior POEM could be performed, depending on the clinical presentation and endoscopist's preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success Rate
Time Frame: 1 day

This involves assessing the procedural success of the POEM using the novel bipolar device. Success would typically mean completing the procedure as planned, without technical difficulties or complications.

Unit of measure: % of procedures
1 day
Clinical Success Rate
Time Frame: 30 days

Clinical success rate is defined as the proportion of patients in whom clinical success (as defined by an Eckardt symptom score ≤ 3) is achieved following the procedure.

The Eckardt score (range 0-12) will be assessed for each patient before the procedure and at the 1 month postoperative follow-up. Clinical success for an individual patient is defined as achieving a follow-up Eckardt score of 3 or less. The clinical success rate is the percentage of patients who meet this success criterion out of the total analyzed population.

Unit of measure: % of patients
30 days
[Safety] Incidence of intraoperative complications
Time Frame: 1 day

Incidence of adverse events occurring during the procedure, including: perforation, bleeding, infection, and any complications directly related to the device.

Unit of measure: % of procedures
1 day
[Safety] Incidence of postoperative complications
Time Frame: 30 days

Incidence of adverse events occurring within 30 days after the procedure, including: perforation, bleeding, infection, and any complications directly related to the device.

Unit of measure: % of procedures
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Procedural Reflux - Symptom Assessment
Time Frame: 30 days

Reflux symptoms reported by the patient after the POEM procedure. Patient-reported symptoms tracked during follow-up visits.

Unit of Measure: Presence/absence and description of symptoms (Categorical).
30 days
Post-Procedural Reflux - Endoscopic Features
Time Frame: 6 months

The presence of esophagitis features identified during endoscopic examination. Endoscopic examination performed at postoperative 6 months follow-up.

Unit of Measure: Presence/absence and grading of esophagitis (Categorical).
6 months
Post-Procedural Reflux - pH Monitoring
Time Frame: 30 days

Quantitative assessment of acid reflux. A pH level below 4 for more than 6% of the monitoring period is considered indicative of significant reflux. Measured by the number of patients with significant reflux at postoperative 1 month follow-up divided by total number of patients.

Unit of measure: % of patients
30 days
Distensibility of the Lower Esophageal Sphincter (LES)
Time Frame: 6 months

The distensibility of the LES, an important parameter in Achalasia treatment, will be measured using the EndoFLIP® system during the 6-month follow-up endoscopic examination. It is measured as the Distensibility Index (DI).

Unit of Measure: mm²/mmHg for DI.
6 months
Postoperative Northwestern Esophageal Quality of Life questionnaire (NEQOL) score
Time Frame: 6 months

The NEQOL questionnaire, a tool designed to measure the quality of life specifically in patients with esophageal conditions, will be administered 6 months post-procedure. The NEQOL questionnaire is consisted of 14 questions answered on a 5-point Likert scale, where higher score means a better health-related quality of life (HRQOL).

Unit of Measure: score (0-56)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Academy tertiary center, IECED, Guayaquil, Ecuador

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2024.464

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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