RFA Knife for POEM in Esophageal Disorders
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
How is the RFA Knife for POEM treatment different from other treatments for esophageal disorders?
The RFA Knife for POEM treatment, involving the Speedboat device, is unique because it combines radiofrequency ablation (a technique using heat to remove tissue) with endoscopic surgery, allowing for precise cutting and coagulation in a minimally invasive manner. This approach is different from traditional surgical methods, which may be more invasive and have higher complication rates.12345
What is the purpose of this trial?
This trial is testing a new surgical tool called the Speedboat-RSD knife for patients with esophageal muscle issues. The tool aims to make the procedure faster and less painful by combining cutting and bleeding control in one device. The Speedboat-RS2 (Creo-Medical, UK) is a novel device which has shown promising results for similar procedures.
Eligibility Criteria
This trial is for adults over 18 who can give consent and are scheduled for a POEM procedure to treat esophageal muscular disorders. It's not open to pregnant individuals, those unable to consent, or prisoners.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the POEM procedure using either the monopolar or bipolar electrocautery tool
Immediate Post-procedure Monitoring
Participants' pain levels are assessed using a Visual Analog Scale at multiple intervals up to 24 hours post-procedure
Follow-up
Participants are monitored for adverse events and technical success of the procedure
Treatment Details
Interventions
- Speedboat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor