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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
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Johan Nordenstam, University of Illinois at Chicago

Brief Summary:

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age and older.
  2. Patients undergoing treatment for symptomatic hemorrhoids using the HET device

Exclusion Criteria:

  1. All patients not included in Inclusion Criteria
  2. Patients with inflammatory bowel disease, malignancy, anal fissures and those who are subject to anti-coagulation therapy with any drug other than aspirin.

Information from the National Library of Medicine

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


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Medtronic
Investigators
Principal Investigator: Johan Nordenstam, MD University of Illinois at Chicago