Hemorrhoids Clinical Trial
Official title:
Feasibility Study of a New Circular Anal Dilator for Transanal Hemorrhoidectomy
NCT number | NCT00693459 |
Other study ID # | 07-07-06 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2008 |
Est. completion date | June 2011 |
Verified date | January 2013 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to test the effectiveness of a new anoscope used while performing a traditional hemorrhoidectomy.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals of Cleveland Case Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center | Ethicon, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the safety of the new device by the number of participants with Adverse Events | This study will be monitored to ensure the identification, documentation and analysis of all adverse events in regards to safety and efficacy of the new device. All adverse events, unforeseen or otherwise will be recorded as data. Information will be reported on the 1)Visual Analog Pain scores, 2)Incontinence score, using the Wexner Oliveira score, 3) Presence of Stenosis 4) Continued bleeding or symptoms, 5) Wound Infection, 6) Bladder Retention | 1 year post-operative | |
Secondary | Evaluate the efficacy of the new device by the number of participants with Adverse Events | This study will be monitored to ensure the identification, documentation and analysis of all adverse events in regards to safety and efficacy of the new device. All adverse events, unforeseen or otherwise will be recorded as data. Information will be reported on the 1)Visual Analog Pain scores, 2)Incontinence score, using the Wexner Oliveira score, 3) Presence of Stenosis 4) Continued bleeding or symptoms, 5) Wound Infection, 6) Bladder Retention | 1 year post operative |
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