Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:7/16/2013
Start Date:January 2011
End Date:May 2013
Contact:Tam LaFleur
Email:tam.lafleur@covidien.com
Phone:203-821-4744

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Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)


The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse
Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based
on the primary endpoint.


Inclusion Criteria:

- The subject is able to understand and sign Informed Consent Form

- The subject is between 18-85 years of age.

- The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled
hemorrhoidopexy

Exclusion Criteria:

- The procedure is needed as revision hemorrhoid surgery.

- Any female patient, who is pregnant, suspected pregnant, or nursing.

- 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 1 year 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 has taken aspirin, anti-coagulation and/or anti platelet therapies
(e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.

- The participant has a history of fecal incontinence

- The participant has had injection therapy, infrared laser treatment or rubber band
ligation for treatment of hemorrhoids within 1 month of screening

- The participant has co-morbidities which, in the opinion of the investigator, will
not be appropriate for the study.
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