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Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01169311
First received: July 22, 2010
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

Trial Objectives

The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:

overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.


Condition Intervention Phase
Hemorrhoid
 Device: THE COVIDIEN EEA™ HEMORRHOID AND PROLAPSE STAPLING SET
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Safety and Efficacy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:

    overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.



Enrollment: 30
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: THE COVIDIEN EEA™ HEMORRHOID AND PROLAPSE STAPLING SET
    The Covidien EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease.
    Other Name: THE COVIDIEN EEA™ HEMORRHOID AND PROLAPSE STAPLING SET
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to understand and sign Informed Consent Form
  • The participant must be 18-80 years of age.
  • The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.

Exclusion Criteria:

  • The procedure is needed as revision hemorrhoid surgery.
  • The participant is pregnant.
  • The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
  • The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
  • The participant has a history of drug or alcohol abuse.
  • The participant has a history of venous thrombosis or pulmonary embolism.
  • The participant has a history of coagulopathy.
  • The participant is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
  • The participant has a history of fecal incontinence.
  • The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169311

Locations
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Sang Lee, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01169311     History of Changes
Other Study ID Numbers: COVHEPH0021
Study First Received: July 22, 2010
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
Hemorrhoids
Hemorrhoid
grade II, III, IV

Additional relevant MeSH terms:
Hemorrhoids
Prolapse
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 17, 2012