Closure type for Gastrointestinal Tumors

Baylor College of Medicine, Houston, TX
Gastrointestinal TumorsClosure type - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing two ways to close a hole in the intestine after removing a polyp.

Eligible Conditions
  • Gastrointestinal Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Phasix™ Mesh
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Permacol biologic mesh

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: For 24 hours following procedure

Day 3
Hemorrhage
Day 1
Cost of each closure
Rate of second modality of defect closure
Day 1
Successful Tissue approximation
Day 1
Rate of complete closure of GI defect
Hour 24
Pain score post-procedure
Within 2 weeks
Adverse Events
Incidence of post-polypectomy syndrome
Year 1
Hospital Length of Stay (LOS)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
VenaSeal™ Closure System
1
Phasix™ Mesh
2
Permacol biologic mesh

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

X-Tack suturing group
1 of 2
Through-the-Scope clip group
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Closure type · No Placebo Group · N/A

Through-the-Scope clip group
Procedure
Experimental Group · 1 Intervention: Closure type · Intervention Types: Procedure
X-Tack suturing group
Procedure
ActiveComparator Group · 1 Intervention: Closure type · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: for 24 hours following procedure

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
945 Previous Clinical Trials
5,979,923 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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).
You have a hole in your body that is larger than 3 centimeters after a surgery.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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