HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment
Completed · Not applicable
Conditions studied: Hemorrhoids
In brief
Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients previously. Methods: Patients seen at a colorectal clinic in a single institution with grade I-II hemorrhoids are offered to participate in a prospective pilot trial. The HET device is a modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of hemorrhoids are treated with 2 heat energy applications per column. The primary outcome is the treatment effect on hemorrhoid symptoms of bleeding, pain, prolapse, itching, and soiling. This is measured with a patient completed questionnaire documenting each symptom's frequency from 0 to 3 (i.e. 0 is \< 1x/month; 3 is daily) before therapy and at 3 weeks and 6 month follow-up. Post-treatment pain scores were recorded using the visual analog scale (VAS).
Key facts
- Study ID
- NCT02773420
- Run by
- University of Illinois at Chicago
- People needed
- 35
- Starts
- 2015-08-01
- Expected to finish
- 2019-01-01
- Last updated by the study team
- 2021-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age and older.
- Patients undergoing treatment for symptomatic hemorrhoids using the HET device
You may not qualify if…
- All patients not included in Inclusion Criteria
- Patients with inflammatory bowel disease, malignancy, anal fissures and those who are subject to anti-coagulation therapy with any drug other than aspirin.
Where it is running
- University of Illinois at Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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