Using the SpydrBlade Flex device during POEM for achalasia and EGJ outflow obstruction
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
NA · Chinese University of Hong Kong · NCT07406945
This will test whether using the SpydrBlade Flex device during POEM is safe and effective for adults with achalasia or EGJ outflow obstruction.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 2 sites (Guayaquil and 1 other locations) |
| Trial ID | NCT07406945 on ClinicalTrials.gov |
What this trial studies
Adults referred for per-oral endoscopic myotomy (POEM) will undergo the procedure using the SpydrBlade Flex bipolar device and be followed for clinical and safety outcomes. Symptom severity will be tracked with the Eckardt Symptom Score and procedural success monitored with imaging and endoscopic findings such as timed barium esophagram and EGD. Adverse events and intraoperative metrics will be recorded to characterize safety. Exclusion criteria include contraindications to EGD, Eckardt score under 3, positive Chagas disease, or inability to tolerate general anesthesia.
Who should consider this trial
Good fit: Adults aged 18 or older referred for POEM for achalasia, failed prior myotomy, prior dilation, or EGJ outflow obstruction who can consent and tolerate general anesthesia are ideal candidates.
Not a fit: Patients with contraindications to EGD, an Eckardt score under 3 before POEM, a positive diagnosis of Chagas disease, or inability to undergo general anesthesia would not be expected to benefit or are excluded.
Why it matters
Potential benefit: If successful, the SpydrBlade Flex could make POEM procedures safer and improve symptom relief for patients with achalasia or EGJ outflow obstruction.
How similar studies have performed: Bipolar electrosurgical tools have been used in endoscopic myotomy with some promising reports, but the SpydrBlade Flex is a relatively new device and direct device-specific evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guayaquil and 1 other locations
- academy tertiary, IECED — Guayaquil, Ecuador (RECRUITING)
- Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Hon Chi Yip
- Email: hcyip@surgery.cuhk.edu.hk
- Phone: +852 3505 2956
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.
Conditions: Achalasia, EGJ Outflow Obstruction, Novel Flexible Bipolar, POEM