NCT01706822

Brief Summary

To evaluate the Radial Reload Stapler during laparoscopic low anterior resection (LAR) or anterior proctosigmoidectomy for rectal cancer by assessing the primary and secondary endpoints.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_4 colorectal-cancer

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_4 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 18, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

October 11, 2012

Results QC Date

February 13, 2015

Last Update Submit

March 17, 2015

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met

    The surgeon's ability to achieve a staple line at the desired level of the rectum.

    Operative

  • The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met

    The ability to achieve adequate distal margins (defined as \>2cm \[or \>1cm with clear histologic evaluation\]) in the low rectum.

    Operative

Secondary Outcomes (3)

  • Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree

    Operatively

  • Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree

    Operatively

  • Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree

    Operatively

Study Arms (1)

Covidien Radial Reload Stapler with Tri-Staple Technology

EXPERIMENTAL

Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic LAR or proctosigmoidectomy

Device: Covidien Radial Reload Stapler with Tri-Staple Technology

Interventions

Covidien Radial Reload Stapler with Tri-Staple TechnologyDEVICE

Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler

Covidien Radial Reload Stapler with Tri-Staple Technology

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is able to understand and sign Informed Consent Form.
  • The subject is between 18-85 years of age.
  • The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection.
  • The subject is anticipated to undergo mobilization and stapling of the rectum laparoscopically.

You may not qualify if:

  • Any female patient, who is pregnant, suspected pregnant, or nursing.
  • The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
  • The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for 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

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Julie Doyle
Organization
Covidien
Julie.Doyle@Covidien.com
781-839-1729

Study Officials

  • Conor Delaney, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 15, 2012

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 18, 2015

Results First Posted

March 18, 2015

Record last verified: 2015-03

Locations

US(1)