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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is comparing two ways to do a Per Oral Endoscopic Myotomy (POEM) procedure, which is used to treat various esophageal disorders. They are comparing the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife, and hypothesize that the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain score

Secondary outcome measures

Adverse events

Hospital Length-of-stay

Study knife removal during procedure

+2 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,000 Previous Clinical Trials

6,001,825 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies in this experiment for participants?

"According to the details found on clinicaltrials.gov, this medical trial is currently looking for new participants. The study was initially posted February 22nd 2022 and has been modified through March 31st of that same year."

Answered by AI

What is the aggregate amount of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov records suggest that this trial is actively enrolling participants, having been posted on February 22nd 2022 and updated as of March 31st 2022. 84 patients are needed across 1 clinical site to complete the study."

Answered by AI

Recent research and studies

Endoscopy International OpenJournal

Feasibility of Speedboat RS2 with Bipolar Radiofrequency Energy for Peroral Endoscopic Myotomy in Patients with Achalasia (with Video)

Patil, Gaurav, Anki Dalal, and Amit P. Maydeo. 2020. “Feasibility of Speedboat RS2 with Bipolar Radiofrequency Energy for Peroral Endoscopic Myotomy in Patients with Achalasia (with Video)”. Endoscopy International Open. Georg Thieme Verlag KG. doi:10.1055/a-1165-0087.

EndoscopyJournal

Risk of Electrocoagulation Syndrome After Endoscopic Submucosal Dissection in the Colon and Rectum

Jung, Dahyun, Young Youn, Jaehoon Jahng, Jie-Hyun Kim, and Hyojin Park. 2013. “Risk of Electrocoagulation Syndrome After Endoscopic Submucosal Dissection in the Colon and Rectum”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/s-0033-1344555.

clinicaltrials.govStudy

Monopolar and Bipolar Current RFA Knife in POEM

Salmaan Azam Jawaid, MD 2022. "Monopolar and Bipolar Current RFA Knife in POEM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05272046.