Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Polypectomy is the medical term for removing polyps. Polyps are abnormal like growths that protrude into the lining of the bowel. Because a polyp cannot always be removed by a snare, the usual and simplest method, (for example, it may be too flat), a doctor (colorectal surgeon) may perform a polypectomy using a technique called Endoscopic Mucosal Resection (EMR). Endoscopic Mucosal Resection (EMR)is based on the concept that endoscopy (looking at the inside of your colon with an instrument called a colonoscope) provides visualization and access to the innermost lining of the gastrointestinal tract, where a polyp originates. The Endoscopic Mucosal Resection (EMR)performed during this study will be standard of care according to the current practice at University Hospitals of Cleveland.
Following polyp removal, the study procedure will be performed. A medical device is being evaluated to help with this procedure by closing the wound that remains after the polyp is removed without performing an open surgical operation. This involves suturing (sewing) the tissue back together with a Tissue Apposition System (TAS). This is also called tissue approximation. The sewing device being evaluated has been cleared by the Food and Drug Administration (FDA).
Up to 20 men and women, at least 21 years of age, requiring removal of a colonic or rectal polyp that cannot be removed by traditional colonic polypectomy, will be asked to enroll in the study. Following polyp removal, these patients will have the remaining tissue area closed using the study sewing device. Participation in this study will last approximately three months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals, Case Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 21 years of age;
- Willing to give consent and comply with evaluation and treatment schedule;
- Approved for polypectomy per standard preoperative endoscopic evaluation;
- Established indication for a procedure greater than colonoscopy and colonic polypectomy. This will include polyps not suitable for current practice (snare procedure) endoscopic resection by nature of size or location, in which an intestinal resection, laparoscopic-assisted polypectomy is required;
- Surgical area viewable with laparoscopy.
Exclusion Criteria:
- Physical or psychological condition which would impair study participation;
- Unable or unwilling to attend follow-up visits and examinations;
- Concurrent surgical procedure;
- Pregnancy;
- A polyp which appears to be an invasive cancer, even with negative pathology;
- A polyp with biopsies suspicious for invasive cancer;
- Participation in any other investigational device or drug study within 30 days prior to enrollment; or
- Any condition which precludes compliance with the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enrolled Subjects treated with TAS device
All enrolled subjects treated with the Tissue Apposition System (TAS) device
|
Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)
Time Frame: At The Time of Surgery
|
Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.
|
At The Time of Surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.
Time Frame: 3 month follow-up
|
The total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.
|
3 month follow-up
|
|
Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition
Time Frame: 3 month follow-up
|
3 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Conor P Delaney, MD MCh PhD FRCSI FACS, University Hospitals Cleveland Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI-07-0004
- UH IRB #07-07-08
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