Endoscopic Knives for Gastrointestinal Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a prospective, randomized trial that aims to study the efficacy and clinical outcomes of a novel Bipolar Knife vs. Monopolar Knives on patients who undergo endoscopic submucosal dissection (ESD) procedure at Baylor St. Luke's Medical Center.

Eligibility Criteria

This trial is for adults over 18 who need an endoscopic submucosal dissection (ESD) procedure for gastrointestinal tumors. They must be able to give informed consent. It's not open to those with lesions removed by other methods, under 18s, those unable to consent, or pregnant women.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I am 18 years old or older.

I am referred for a procedure to remove a growth in my digestive tract.

Exclusion Criteria

Patient is a pregnant woman

Patient refused and/or unable to provide consent

I am under 18 years old.

+1 more

Participant Groups

The study compares the effectiveness of a new Bipolar Knife versus traditional Monopolar Knives in ESD procedures at Baylor St. Luke's Medical Center. Patients are randomly assigned one of the two surgical tools to see which performs better.

2Treatment groups

Experimental Treatment

Active Control

Group I: Bipolar KnifeExperimental Treatment2 Interventions

ESD procedure performed with a novel bipolar knife.

Group II: Monopolar KnifeActive Control2 Interventions

ESD procedure performed with monopolar knives.