Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00553436
First received: November 2, 2007
Last updated: April 20, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Polyps
Device: Tissue Apposition System (TAS) Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) [ Time Frame: At The Time of Surgery ] [ Designated as safety issue: No ]
    Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enrolled Subjects treated with TAS device
All enrolled subjects treated with the Tissue Apposition System (TAS) device
Device: Tissue Apposition System (TAS) Device
Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553436

Locations
United States, Ohio
University Hospitals, Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Conor P Delaney, MD MCh PhD FRCSI FACS University Hospital Case Medical Center
  More Information

No publications provided by Ethicon Endo-Surgery

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amy Mahanes, Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00553436     History of Changes
Other Study ID Numbers: CI-07-0004, UH IRB #07-07-08
Study First Received: November 2, 2007
Results First Received: October 20, 2009
Last Updated: April 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ethicon Endo-Surgery:
colon
rectum
polyp
EMR
Established indication for a procedure greater than colonoscopy and colonic polypectomy

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 26, 2014