New tool could make achalasia surgery safer and more effective
NCT ID NCT07406945
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device called SpydrBlade Flex for a procedure that helps people with achalasia, a condition where the esophagus doesn't relax properly, making swallowing difficult. The device uses radiofrequency and microwave energy to cut muscle. Researchers will check if the procedure works well and is safe in 73 adults. The goal is to improve swallowing and reduce complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SpydrBlade Flex device (radiofrequency and microwave ablation tool)
- What this could lead to
- If successful, this device could make the POEM procedure safer and more effective for treating achalasia, improving swallowing and quality of life.
- What could go wrong
- This is an early-stage study with only 73 participants. The device may not work better than existing tools, and risks like bleeding or infection remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 73 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
RECRUITINGHong Kong, Hong Kong
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academy tertiary, IECED
RECRUITINGGuayaquil, Ecuador
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New registry tracks POEM procedure for swallowing disorder
- New study investigates why some patients get worse reflux after esophagus surgery
- Small study seeks clues to weight loss mystery in achalasia
- Shingles virus in the gut linked to swallowing disorder – new trial aims to treat it