Status:
TERMINATED
Comparison Study of Hemorrhoid Surgery Using the Enseal Device to Standard Hemorrhoid Surgical Techniques
Lead Sponsor:
Swedish Medical Center
Conditions:
Hemorrhoids
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques. It is hypothesized ...
Detailed Description
The EnSeal Device is FDA approved for surgery in ligating and dividing vascular tissue during abdominal surgery. Electrical energy is converted into heat energy and resultant simultaneous division of ...
Eligibility Criteria
Inclusion
- Men and women between ages 18 through 80
- American Society of Anesthesiologists (ASA) level I, II and III
- External hemorrhoids must be present and deemed sufficiently symptomatic to warrant removal
- Internal hemorrhoids at least Grade II
- Must be able to be seen post-operatively by the surgeon at 3 to 4 weeks and 3 months after surgery
Exclusion
- American Society of Anesthesiologists (ASA) level IV
- Grade I internal hemorrhoids
- Currently receiving coumadin, plavix, or other anticoagulants
- No prior sphincterotomy, drainage of abscess, fistulotomy, or similar procedures
- No pregnant women at the time of surgery
- No lactating women
- No inflammatory bowel disease
- No history of chronic, active hepatitis B, C, or HIV infection
- No prior chronic narcotic use (more than 30 days)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01422473
Start Date
August 1 2011
End Date
January 1 2013
Last Update
June 5 2013
Active Locations (1)
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1
Swedish Medical Center Colon Rectal Clinic
Seattle, Washington, United States, 98104