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
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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