Polyps Clinical Trial
Official title:
Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
Verified date | April 2010 |
Source | Ethicon Endo-Surgery |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals, Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ethicon Endo-Surgery |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | At The Time of Surgery | No |
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. | 3 month follow-up | No |
Secondary | Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition | 3 month follow-up | No |
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