RFA Knife for POEM in Esophageal Disorders

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different tools for a procedure that treats esophageal disorders like achalasia, which makes swallowing difficult. The researchers aim to determine if a new bipolar tool, called the Speedboat, can reduce pain compared to the usual monopolar tool. Individuals advised to undergo a POEM procedure for their esophageal condition may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to advancements in esophageal treatments.

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.

What prior data suggests that the Speedboat-RSD knife is safe for POEM procedures?

Research has shown that the Speedboat-RSD, a tool used to stop bleeding during surgery, is generally safe for procedures like POEM. In studies, patients who underwent POEM with the Speedboat-RSD experienced no immediate problems and were able to go home the next day without issues. Follow-up checks with a camera six weeks later also revealed no problems.

One study found that this tool was successful in over 98% of cases. However, there was a 39% rate of minor side effects, which were usually not serious. The FDA has approved the Speedboat-RSD for other uses in the digestive system, indicating its safety for these types of procedures.

Overall, evidence suggests that the Speedboat-RSD is well-tolerated and safe for procedures like POEM, with few serious issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of different electrocautery tools for POEM (Peroral Endoscopic Myotomy) procedures in treating esophageal disorders. Unlike the standard monopolar electrocautery tool, which is the current norm, this trial investigates both the existing monopolar and a novel bipolar electrocautery tool. The bipolar tool is of particular interest because it may offer more precise energy delivery, potentially reducing tissue damage and improving patient outcomes. This trial could lead to advancements in how we perform POEM procedures, making them safer and more effective for patients with esophageal disorders.

What evidence suggests that the Speedboat-RSD knife is effective for esophageal disorders?

Research has shown that the Speedboat-RSD knife holds promise for treating esophageal disorders like achalasia. Studies indicate that using the Speedboat-RSD in a POEM procedure, a type of endoscopic surgery, is generally safe and effective, with a success rate exceeding 98%. Patients typically experience fewer complications and less pain afterward. This tool enables the procedure to be performed quickly and efficiently, reducing the need to switch instruments multiple times. Although the Speedboat-RSD remains under study, early results are encouraging for its use in these procedures. In this trial, participants will be randomized to receive either the standard monopolar electrocautery tool or the bipolar electrocautery tool for their POEM procedure. ^{1 2 3 4 6}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7373652/

Feasibility of Speedboat RS2 with bipolar radiofrequency ... Early experience shows that Speedboat-RS2 is feasible for performing POEM with good safety profile. Submucosal tunneling was relatively quick and coagulation ...

2. researchgate.net researchgate.net/publication/343121134_Feasibility_of_Speedboat_RS2_with_bipolar_radiofrequency_energy_for_peroral_endoscopic_myotomy_in_patients_with_achalasia_with_video

Feasibility of Speedboat RS2 with bipolar radiofrequency ... At 6 weeks, endoscopy was uneventful and the patients were asymptomatic. Conclusions Early experience shows that Speedboat-RS2 is feasible for ...

3. shc.amegroups.org shc.amegroups.org/article/view/6010/html

Peroral endoscopic myotomy: techniques and outcomes - Petrov Analysis revealed a technical success rate of greater than 98% and a rate of insignificant adverse events of 39%. POEM appears to be a safe and effective ...

4. cghjournal.org cghjournal.org/article/S1542-3565(24)00451-8/fulltext

Recent Advancements and Future Perspectives of Per Oral ... In the published studies, the technical and clinical success with POEM in EED ranges from 92% to 100% and 85% to 100%, respectively. The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8130836/

Peroral endoscopic myotomy: techniques and outcomes Analysis revealed a technical success rate of greater than 98% and a rate of insignificant adverse events of 39%. POEM appears to be a safe and effective ...

6. videogie.org videogie.org/article/S2468-4481(23)00164-9/fulltext

Gastric peroral endoscopic myotomy using a novel bipolar ... The patient did well after the procedure with no immediate or delayed adverse events. He also had significant symptomatic improvements, and GCSI ...