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Not Applicable
Closure Type for Gastrointestinal Tumors
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
Study Summary
This trial is testing two ways to close a hole in the intestine after removing a polyp.
Eligible Conditions
- Gastrointestinal Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cost of each closure
Secondary outcome measures
Rate of complete closure of GI defect
Successful Tissue approximation
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
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,098 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate of participants involved in this experiment?
"Affirmative. According to clinicaltrials.gov, this experiment is presently soliciting participants and was first listed on August 9th 2022; the details were last amended on August 2nd 2022. The study aims to enrol 100 people from 1 centre."
Answered by AI
Is this experiment accepting new participants at the moment?
"Indeed, according to the information on clinicaltrials.gov, this trial is currently seeking study participants. It was first posted on August 9th 2022 and has been updated as recently as August 2nd of the same year. There are 100 spots available across 1 particular location."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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