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HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment (HET)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Johan Nordenstam, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02773420
First received: May 12, 2016
Last updated: May 30, 2016
Last verified: May 2016
  Purpose

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 Intervention
Hemorrhoids Procedure: HET Application

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HET Bipolar System: Validation of a New Minimally Invasive Outpatient Treatment for Symptomatic Hemorrhoids

Resource links provided by NLM:


Further study details as provided by Johan Nordenstam, University of Illinois at Chicago:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 30
Study Start Date: August 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Johan Nordenstam, Assistant Professor of Surgery, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02773420     History of Changes
Other Study ID Numbers: 2015-0701
ISR-2015-10644 ( Other Grant/Funding Number: Medtronic )
Study First Received: May 12, 2016
Last Updated: May 30, 2016

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 22, 2017