← Back to Search

ESD with traction device for Gastrointestinal Neoplasms

N/A

Recruiting

Led By Mohamed Othman, MD

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 referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria: A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

Patient is ≥ 18 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month post-procedure

Awards & highlights

Study Summary

This trial hopes to see if a traction device can help make colonic endoscopic submucosal dissections faster and more successful.

Who is the study for?

This trial is for adults over 18 who need an ESD procedure for colonic neoplastic lesions. They must be able to consent and have specific types of lesions, including those with scars or certain sizes. It's not for pregnant women, minors, or patients with pedunculated lesions or those near the appendix or ileocecal valve.Check my eligibility

What is being tested?

The study at Baylor St. Luke's Medical Center is testing if using a traction device during colonic ESD can make the procedure faster and more effective compared to the standard method without traction.See study design

What are the potential side effects?

While specific side effects are not listed, ESD procedures may include risks such as bleeding, perforation of the colon wall, abdominal pain, and infection. The addition of a traction device could potentially alter these risks.

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 post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month post-procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dissection speed

Secondary outcome measures

Abdominal pain

En-bloc, R0, and curative resection rates

Intraprocedural adverse events

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ESD with traction deviceExperimental Treatment2 Interventions

ESD of target lesion will be performed with the assistance of a traction device.

Group II: Control armActive Control1 Intervention

ESD of target lesion will be performed without the use of a traction device

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endoscopic Submucosal Dissection

2009

N/A

~340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Micro-Tech Endoscopy USAUNKNOWN

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,262 Total Patients Enrolled

8 Trials studying Gastrointestinal Neoplasms

944 Patients Enrolled for Gastrointestinal Neoplasms

Mohamed Othman, MDPrincipal InvestigatorBaylor College of Medicine

3 Previous Clinical Trials

208 Total Patients Enrolled

1 Trials studying Gastrointestinal Neoplasms

66 Patients Enrolled for Gastrointestinal Neoplasms

Frequently Asked Questions

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

Are researchers still recruiting participants for this research study?

"Reportedly, no longer recruiting patients, this study was initially announced on November 28th 2023 and last revised on the same day. Although enrollment is not possible at present, 159 other clinical trials are actively seeking participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Traction vs. No Traction in Colonic ESD

Mohamed Othman, MD 2023. "Traction vs. No Traction in Colonic ESD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06159634.