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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
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give my consent for treatment.

Timeline

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.

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.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,025 Previous Clinical Trials
6,029,677 Total Patients Enrolled

Media Library

Speedboat (Electrosurgical Device) Clinical Trial Eligibility Overview. Trial Name: NCT05272046 — N/A
Esophageal Motility Disorder Research Study Groups: Monopolar Electrocautery tool, Bipolar Electrocautery tool
Esophageal Motility Disorder Clinical Trial 2023: Speedboat Highlights & Side Effects. Trial Name: NCT05272046 — N/A
Speedboat (Electrosurgical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05272046 — N/A
~6 spots leftby Feb 2025