HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment (HET)
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|ClinicalTrials.gov Identifier: NCT02773420|
Recruitment Status : Unknown
Verified May 2016 by Johan Nordenstam, University of Illinois at Chicago.
Recruitment status was: Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : June 1, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Procedure: HET Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HET Bipolar System: Validation of a New Minimally Invasive Outpatient Treatment for Symptomatic Hemorrhoids|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||March 2017|
Experimental: HET application arm
Patients with grade I-II internal hemorrhoids will undergo HET application
Procedure: HET Application
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 were treated with 2 heat energy applications per column
- HET Treatment effect on hemorrhoid symptoms [ Time Frame: 3 weeks to 6 months to 1 year ]The effect of HET on symptoms of bleeding, pain, prolapse, itching, and soiling.
- Pain associated with HET [ Time Frame: Immediately to 3 weeks to 2 months ]Evaluation of pain associated with the procedure itself using visual analog scale for pain to record outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773420
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Johan Nordenstam, MD||University of Illinois at Chicago|