What side effects are associated with this type of intervention?

Common treatments for esophageal motility disorders, such as Peroral Endoscopic Myotomy (POEM), which involve tissue dissection and hemostasis, have side effects including post-procedural pain, bleeding, and perforations. These complications are typically managed conservatively. Another potential side effect is the development of reflux esophagitis. Given the procedural similarities, treatments using the Speedboat-RSD knife may have a similar side effect profile.

What prior FDA approvals exist?

The FDA has approved various treatments for esophageal motility disorders, including pharmacologic agents like proton pump inhibitors (PPIs) and prokinetics. Additionally, procedural interventions such as Peroral Endoscopic Myotomy (POEM) have been approved for conditions like achalasia. The Speedboat-RSD knife, which uses bipolar energy for tissue dissection and hemostasis, is a newer tool being studied for its efficacy in POEM procedures. This device aims to improve procedural efficiency and reduce post-procedural pain compared to traditional monopolar energy devices.

What other types of research exist?

Promising alternatives to the Speedboat-RSD knife for esophageal motility disorder patients include the standard monopolar ERBE knife, which is commonly used in Peroral Endoscopic Myotomy (POEM) procedures. Additionally, advancements in endoscopic submucosal dissection (ESD) techniques, which utilize various endoscopic electrosurgical needle knives, may also serve as effective alternatives. These methods are known for their precision in tissue dissection and hemostasis, and are performed in specialized centers with high success rates.

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Electrosurgical Device

RFA Knife for POEM in Esophageal Disorders

N/A

Waitlist Available

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years of age

Be older than 18 years old

Must not have

Unable to sign consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 3 months, 6 months, and 12 months.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort or pain at the site of surgery, risks associated with endoscopic procedures such as bleeding or infection, and possible adverse reactions specific to the type of cautery knife used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to give my consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 3 months, 6 months, and 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 3 months, 6 months, and 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 months, 6 months, and 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain score

Secondary study objectives

Adverse events

Hospital Length-of-stay

Study knife removal during procedure

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Esophageal Motility Disorder, such as Peroral Endoscopic Myotomy (POEM), work by reducing the pressure at the lower esophageal sphincter through endoscopic dissection of the esophageal muscle. The Speedboat-RSD knife, which uses bipolar energy for tissue dissection and hemostasis, aims to enhance this procedure by making it more efficient and less painful. This is significant for patients as it can lead to more effective symptom relief and a better overall treatment experience.