Using the SpydrBlade Flex device during POEM for achalasia and EGJ outflow obstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.