NCT00553436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 26, 2010

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

1.4 years

First QC Date

November 2, 2007

Results QC Date

October 20, 2009

Last Update Submit

April 20, 2010

Conditions

Polyps

Keywords

colonrectumpolypEMREstablished indication for a procedure greater than colonoscopy and colonic polypectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition

    3 month follow-up

Study Arms (1)

Enrolled Subjects treated with TAS device

EXPERIMENTAL

All enrolled subjects treated with the Tissue Apposition System (TAS) device

Device: Tissue Apposition System (TAS) Device

Interventions

Tissue Apposition System (TAS) DeviceDEVICE

Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.

Enrolled Subjects treated with TAS device

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals, Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Agrawal D, Chak A, Champagne BJ, Marks JM, Delaney CP. Endoscopic mucosal resection with full-thickness closure for difficult polyps: a prospective clinical trial. Gastrointest Endosc. 2010 May;71(6):1082-8. doi: 10.1016/j.gie.2009.12.036.

    PMID: 20438900DERIVED

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Amy Mahanes, Clinical Research Associate II
Organization
Ethicon Endo-Surgery, Inc
amahanes@its.jnj.com
513-337-8366

Study Officials

  • Conor P Delaney, MD MCh PhD FRCSI FACS

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 2007

First Posted

November 5, 2007

Study Start

November 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 27, 2010

Results First Posted

March 26, 2010

Record last verified: 2010-04

Locations

US(1)