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Procedure

Novel Rigidizing Overtube for Gastrointestinal Cancer

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 ≥ 22 years old
Be older than 18 years old
Must not have
Lesions involving appendiceal orifice or ileocecal valve
Lesions with morphology: pedunculated type (Paris Ip, Ips)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (procedure day)
Awards & highlights

Summary

This trial will compare a new device to conventional treatment for colonic surgery. It's expected to lead to faster procedure times and fewer adverse events.

Who is the study for?
This trial is for individuals at least 22 years old needing a procedure called ESD for colon tumors. They must have specific types of lesions, like those with scars or certain large spreading tumors, and not be located in the sigmoid colon or rectum. Pregnant or nursing women cannot participate.
What is being tested?
The study tests a new device called Pathfinder® Endoscope Overtube during ESD procedures against conventional methods. The aim is to see if this overtube can make the procedure quicker and safer by providing better control over the endoscope.
What are the potential side effects?
While specific side effects are not listed, typical risks may include discomfort at the insertion site, potential bleeding from tissue removal, infection risk post-procedure, and possible adverse reactions related to stability and control issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer affects the appendix opening or the valve between the small and large intestines.
Select...
My lesion is a type that sticks out on a stalk.
Select...
My cancer is in the sigmoid colon or rectum.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (procedure day)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (procedure day) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Procedure Time
Secondary outcome measures
Clinical Success
Closure time
Dissection speed during colonic ESD as calculated by
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment armExperimental Treatment2 Interventions
Will have endoscopic submucosal dissection performed with the use of the Pathfinder Endoscope Overtube.
Group II: Control armActive Control1 Intervention
Will have endoscopic submucosal dissection performed through conventional means (i.e. without the Pathfinder Endoscope Overtube).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endoscopic Submucosal Dissection
2009
N/A
~340

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,363 Total Patients Enrolled
8 Trials studying Gastrointestinal Neoplasms
1,028 Patients Enrolled for Gastrointestinal Neoplasms
Neptune Medical, Inc.UNKNOWN
Mohamed Othman, MDPrincipal InvestigatorBaylor College of Medicine
3 Previous Clinical Trials
292 Total Patients Enrolled
1 Trials studying Gastrointestinal Neoplasms
150 Patients Enrolled for Gastrointestinal Neoplasms
~38 spots leftby Jan 2025
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