Status:
COMPLETED
Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
Lead Sponsor:
Medtronic - MITG
Conditions:
Hemorrhoids, Internal
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Hemorrhoids are vascular cushions in the anal canal. People are normally born with hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids typically cause symptoms wh...
Detailed Description
In this study, the investigators will use the HET Bipolar System for the treatment of Stage I and Stage II hemorrhoids, where significant tissue prolapse is not present. The hemorrhoids are treated by...
Eligibility Criteria
Inclusion
- Subject over 21 years of age
- General good health
- Subject undergoing elective treatment for Stage I or Stage II internal hemorrhoids
- Chronic bleeding from Stage I or Stage II internal hemorrhoids (at least weekly occurrence
- Failure of prior medical management
Exclusion
- Under 21 years of age.
- Gastrointestinal bleeding from source other than their internal hemorrhoids
- Active proctitis
- Inflammatory bowel disease
- HIV positive or immunocompromised
- Rectal wall prolapse
- Stage III and Stage IV hemorrhoids
- Medical conditions requiring anticoagulants and/or subject to receive anticoagulants within 7 days of initial examination
- Pregnancy
- Rectal malignancy
- Hepatitis C
- Liver cirrhosis
- End stage renal disease
- Receiving chemotherapy
- Advanced malignancy
- Documented bleeding diathesis
- Treatment with an investigational drug or medical device in the past 30 days
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01841970
Start Date
April 1 2013
End Date
January 1 2015
Last Update
January 16 2017
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106