RFA Knife for POEM in Esophageal Disorders

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Pregnancy, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

105 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Bipolar Electrocautery tool Experimental Treatment 2 Interventions

Patients randomized into this group will receive the standard of care bipolar tool for their POEM procedure.

Group II: Monopolar Electrocautery tool Active Control 1 Intervention

Patients randomized into this group will receive the standard of care monopolar tool for their POEM procedure.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Case of robot-assisted salvage surgery for esophageal cancer with a mediastinal fistula after definitive chemoradiotherapy. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Short-term outcomes of robot-assisted minimally invasive esophagectomy for esophageal cancer]. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment of hemorrhagic radiation-induced gastritis after esophagectomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of Clinical Outcomes of Robot-Assisted, Video-Assisted, and Open Esophagectomy for Esophageal Cancer: A Systematic Review and Meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Esophageal nightmare: cancer recurrence after definitive chemoradiation. Is salvage esophagectomy possible? [2013]