105 Participants Needed

RFA Knife for POEM in Esophageal Disorders

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I can legally agree to a POEM procedure for my condition.

Exclusion Criteria

I am unable to give my consent for treatment.
Pregnant patients
Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the POEM procedure using either the monopolar or bipolar electrocautery tool

1 day
1 visit (in-person)

Immediate Post-procedure Monitoring

Participants' pain levels are assessed using a Visual Analog Scale at multiple intervals up to 24 hours post-procedure

24 hours
In-hospital monitoring

Follow-up

Participants are monitored for adverse events and technical success of the procedure

12 months
Visits at 1 month, 3 months, 6 months, and 12 months

Treatment Details

Interventions

  • Speedboat
Trial Overview The study compares two types of electrocautery knives used in the POEM procedure: the standard monopolar ERBE knife and the bipolar Speedboat-RSD knife. The goal is to see if the bipolar knife reduces post-procedural pain and increases efficiency.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Bipolar Electrocautery toolExperimental Treatment2 Interventions
Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.
Group II: Monopolar Electrocautery toolActive Control1 Intervention
Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

References

Case of robot-assisted salvage surgery for esophageal cancer with a mediastinal fistula after definitive chemoradiotherapy. [2023]
[Short-term outcomes of robot-assisted minimally invasive esophagectomy for esophageal cancer]. [2018]
Hyperbaric oxygen treatment of hemorrhagic radiation-induced gastritis after esophagectomy. [2022]
Comparison of Clinical Outcomes of Robot-Assisted, Video-Assisted, and Open Esophagectomy for Esophageal Cancer: A Systematic Review and Meta-analysis. [2022]
Esophageal nightmare: cancer recurrence after definitive chemoradiation. Is salvage esophagectomy possible? [2013]
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