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Procedure

Endoscopic Knives for Gastrointestinal 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

Patient is ≥ 18 years old

Patient is referred for ESD procedure of gastrointestinal neoplastic lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Study Summary

This trial is testing a new type of knife against a traditional one to see if it is more effective for a specific medical procedure.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include bleeding, infection, pain at the site of resection, and possible complications related to the use of either knife during the ESD procedure.

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.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Procedure time

Secondary outcome measures

Delayed post-procedural adverse event

Immediate post-procedural adverse event

Procedural adverse event

+1 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endoscopic Submucosal Dissection

2009

N/A

~340

Endoscopic Mucosal Resection

2014

Completed Phase 2

~1090

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,172 Total Patients Enrolled

Frequently Asked Questions

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

What is the cohort size of this clinical experiment?

"Affirmative. The details posted on clinicaltrials.gov demonstrate that this investigation, initially published on the 5th of January 2022, is actively seeking participants. 88 individuals are necessary to be enrolled from 2 distinct medical facilities."

Answered by AI

Is this trial still enrolling participants?

"As indicated on clinicaltrials.gov, the recruiting process for this medical study is ongoing and was last updated on March 11th 2022. The trial was first posted to the website 5 months prior in January of that same year."

Answered by AI

Recent research and studies

BMC GastroenterologyJournal

Safety of Endoscopic Procedures with Monopolar Versus Bipolar Instruments in an Ex Vivo Porcine Model

Shinmura, Kensuke, Hiroaki Ikematsu, Motohiro Kojima, Hiroshi Nakamura, Shozo Osera, Yusuke Yoda, Keisuke Hori, Yasuhiro Oono, Atsushi Ochiai, and Tomonori Yano. 2020. “Safety of Endoscopic Procedures with Monopolar Versus Bipolar Instruments in an Ex Vivo Porcine Model”. BMC Gastroenterology. Springer Science and Business Media LLC. doi:10.1186/s12876-020-1176-9.

EndoscopyJournal

Bipolar Snare Polypectomy – A Safer Technique for Electrocoagulation of Large Polyp Stalks

Williams, C., and R. de Peyer. 1979. “Bipolar Snare Polypectomy – A Safer Technique for Electrocoagulation of Large Polyp Stalks”. Endoscopy. Georg Thieme Verlag KG. doi:10.1055/s-0028-1098324.

Digestive Diseases and SciencesJournal

Prevalence and Clinical Features of Coagulation Syndrome After Endoscopic Submucosal Dissection for Colorectal Neoplasms

Hong, Mi Jin, Jeong Hwan Kim, Sun-Young Lee, In-Kyung Sung, Hyung Seok Park, and Chan Sup Shim. 2014. “Prevalence and Clinical Features of Coagulation Syndrome After Endoscopic Submucosal Dissection for Colorectal Neoplasms”. Digestive Diseases and Sciences. Springer Science and Business Media LLC. doi:10.1007/s10620-014-3484-9.

American Journal of GastroenterologyJournal