Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids (HEMOSTASIS)

Medtronic

Status

Completed

Conditions

Hemorrhoids

Treatments

Device: Endosurgery Proximate PPH03 Stapling Set

Device: EEA Hemorrhoid and Prolapse Stapling Set

Study type

Interventional

Funder types

Industry

Identifiers

NCT01306877

COVHEPH0109

Details and patient eligibility

About

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.

Enrollment

149 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.