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Electrosurgical Device

Endoscopic Submucosal Dissection with Bipolar Electrocautery for Esophageal Cancer

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will compare a new device (Speedboat RS2) to a standard procedure for removing abnormal tissue in the digestive tract.

Who is the study for?

This trial is for adults over 18 with esophageal cancer or polyps who need an Endoscopic Submucosal Dissection (ESD) procedure and can consent to participate. Pregnant women, those under 18, or patients having lesions removed by techniques other than ESD are not eligible.Check my eligibility

What is being tested?

The study aims to compare the effectiveness of a new Bipolar-Current ESD device versus the standard monopolar electrocautery knife in performing ESD procedures on esophageal lesions.See study design

What are the potential side effects?

Potential side effects may include bleeding, infection at the site of dissection, pain following the procedure, and possible complications related to electrocautery such as burns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

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

Speed of Endoscopic Submucosal Dissection

Secondary outcome measures

Adverse events

Curative Resection achieved

En-bloc resection achieved

+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 endoscopic submucosal dissection procedure.

Group II: Monopolar Electrocautery toolActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endoscopic Submucosal Dissection

2009

N/A

~340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,887 Total Patients Enrolled

1 Trials studying Esophageal Neoplasms

32 Patients Enrolled for Esophageal Neoplasms

Media Library

Monopolar electrocautery knife (Electrosurgical Device) Clinical Trial Eligibility Overview. Trial Name: NCT05736705 — N/A

Esophageal Neoplasms Research Study Groups: Monopolar Electrocautery tool, Bipolar Electrocautery tool

Esophageal Neoplasms Clinical Trial 2023: Monopolar electrocautery knife Highlights & Side Effects. Trial Name: NCT05736705 — N/A

Monopolar electrocautery knife (Electrosurgical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05736705 — N/A

Frequently Asked Questions

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

Is eligibility for this trial confined to individuals under the age of 45?

"This medical trial is recruiting participants aged 18 or over and below 90 years of age."

Answered by AI

Could potential participants sign up for this research endeavor?

"This specific medical trial, which was initially posted on February 27th 2023 and last revised two weeks later, is not currently recruiting. However, there are 284 other trials that require participants right now."

Answered by AI

Is my profile compatible with the parameters of this research study?

"This clinical trial is enrolling 65 individuals aged 18 to 90 who have undergone endoscopic submucosal dissection. To be eligible for the study, each patient must be capable of informed consent and referred for ESD procedure on an esophageal neoplastic lesion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monopolar and Bipolar in Esophageal ESD

Salmaan Azam Jawaid, MD 2024. "Monopolar and Bipolar in Esophageal ESD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05736705.