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

NCT01169311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-10-06

Study results available
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Summary

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.

Conditions

  • Hemorrhoid

Interventions

DEVICE

Hemorrhoidopexy

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Sang Lee, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-03-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01169311 on ClinicalTrials.gov