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Not Applicable
Closure Type for Gastrointestinal Tumors
Houston, TX
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two ways to close a hole in the intestine after removing a polyp.
See full description
Eligible Conditions
- Gastrointestinal Tumors
- Gastrointestinal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cost of each closure
Secondary study objectives
Rate of complete closure of GI defect
Successful Tissue approximation
Awards & 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: Through-the-Scope clip groupExperimental Treatment1 Intervention
Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal.
Group II: X-Tack suturing groupActive Control1 Intervention
Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Closure type
2022
N/A
~90
Find a Location
Closest Location:Baylor College of Medicine· Houston, TX
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,040 Previous Clinical Trials
6,030,536 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a hole in your body that is larger than 3 centimeters after a surgery.The tumor or abnormality is located at least 2 centimeters away from the dentate line (the boundary between the lower part of the rectum and the anal canal).
Research Study Groups:
This trial has the following groups:- Group 1: Through-the-Scope clip group
- Group 2: X-Tack suturing group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.