Status:
COMPLETED
Study of a New Circular Anal Dilator
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Hemorrhoids
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this research study is to test the effectiveness of a new anoscope used while performing a traditional hemorrhoidectomy.
Detailed Description
Historically, surgical hemorrhoidectomy has been effective at eliminating hemorrhoids but is associated with high complication rates and post-operative disability. The problems that are most common im...
Eligibility Criteria
Inclusion
- Subjects with internal or external symptomatic hemorrhoids.
- Subjects who have failed, or are not suitable for office management of their hemorrhoids.
- Subjects who are 18 years of age and older
- Subjects of either gender
- Subjects, who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent
Exclusion
- Subjects who have had previous hemorrhoid surgery.
- Subjects with internal hemorrhoids that may be suitable for office management.
- Subjects with incontinence.
- Subjects with evidence of acute sepsis or the presence of a fistula.
- Subjects with a medical condition that may interfere with the evaluation of safety or effectiveness of the study device.
- Subjects who have another condition that in the opinion of the investigator precludes further participation in the study.
- Subjects with an anal stricture.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00693459
Start Date
May 1 2008
End Date
June 1 2011
Last Update
August 15 2022
Active Locations (1)
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1
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106