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Traction Device for Digestive System Tumors
Houston, TX
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.
Must not have
Lesions with morphology: pedunculated type (Paris IP, Ips).
Appendiceal orifice or IC valve lesions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month post-procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial hopes to see if a traction device can help make colonic endoscopic submucosal dissections faster and more successful.
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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 belowSelect...
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.
Select...
I am 18 years old or older.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lesion is pedunculated.
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Select...
I have lesions on my appendix or ileocecal valve.
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Select...
My lesion was removed using a method other than ESD.
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Select...
I am under 18 years old.
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Select...
I am unable or unwilling to give consent for the trial.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dissection speed
Secondary study objectives
Abdominal pain
En-bloc, R0, and curative resection rates
Intraprocedural adverse events
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Closest Location:Baylor College of Medicine· Houston, TX
Who is running the clinical trial?
Micro-Tech Endoscopy USAUNKNOWN
Baylor College of MedicineLead Sponsor
1,040 Previous Clinical Trials
6,030,432 Total Patients Enrolled
9 Trials studying Gastrointestinal Neoplasms
1,044 Patients Enrolled for Gastrointestinal Neoplasms
Mohamed Othman, MDPrincipal InvestigatorBaylor College of Medicine
4 Previous Clinical Trials
248 Total Patients Enrolled
1 Trials studying Gastrointestinal Neoplasms
66 Patients Enrolled for Gastrointestinal Neoplasms