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
  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:


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
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: 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 July 31, 2014