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 |
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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