Polyps
Conditions
Keywords
colon, rectum, polyp, EMR, Established indication for a procedure greater than colonoscopy and colonic polypectomy
Brief summary
The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.
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.
Interventions
DEVICETissue Apposition System (TAS) Device
Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) | At The Time of Surgery | Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition. | 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. |
| Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition | 3 month follow-up | — |
Countries
United States
Participant flow
Recruitment details
Single Center, hospital based surgical suite. Enrollment from 20 August 2007 to 09 April 2009.
Pre-assignment details
Non-randomized. Patients were considered for enrollment based on inclusion / exclusion criteria and were offered the opportunity for enrollment. Those that signed informed consent were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Subjects Treated With Tissue Apposition System (TAS) All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion to another procedure | 1 |
Baseline characteristics
| Characteristic | Enrolled Subjects Treated With Tissue Apposition System (TAS) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age Continuous | 65 years STANDARD_DEVIATION 8.36 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 7 |
| serious Total, serious adverse events | 2 / 7 |
Outcome results
Primary
Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)
Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.
Time frame: At The Time of Surgery
Population: All enrolled subjects were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrolled Subjects Treated With Tissue Apposition System (TAS) | Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) | 6 participants |
Secondary
Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition
Time frame: 3 month follow-up
Population: All enrolled subjects were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrolled Subjects Treated With Tissue Apposition System (TAS) | Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition | 6 Participants |
Secondary
Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.
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.
Time frame: 3 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrolled Subjects Treated With Tissue Apposition System (TAS) | Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition. | 6 participants |