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Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT01841970
First received: April 22, 2013
Last updated: November 17, 2016
Last verified: November 2016
  Purpose

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 when they enlarge over time. There are two types of hemorrhoids- External Hemorrhoids and Internal Hemorrhoids.

Current minimally invasive technologies for the treatment of internal hemorrhoids are associated with several drawbacks that include high rate of recurrence and a need for repetitive procedures, frequent post-procedural pain or significant discomfort, intra-operative pain and technically demanding. The purpose of this study is to determine whether the HET Bipolar System is safe and effective in the treatment of Stage I and Stage II hemorrhoids (internal hemorrhoids). The HET Bipolar System is a new alternative device for the minimally invasive treatment of Stage I and Stage II hemorrhoids that incorporate design features with the intent of resolving each of the major limitations of currently available technology.


Condition Intervention
Hemorrhoids, Internal Device: HET Bipolar System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center, Prospective Study of the Safety and Efficacy of the HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids

Resource links provided by NLM:


Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • Number of Participants With Resolution of Symptoms [ Time Frame: Post treatment at Month1, Month 3, Month 6 ]
    The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment


Secondary Outcome Measures:
  • Incidence of Recurrence of Pre-procedure Symptoms [ Time Frame: Post treatment at Month 1, Month 3, and Month 6 ]
    Recurrence of pre-procedure symptoms after initial improvement

  • Recurrence of Symptoms That Had Resolved With Treatment [ Time Frame: Post treatment at Month 1, Month 3, Month 6 ]
    Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.

  • Pain Recorded Yes or No on Visual Analog Scale (VAS) [ Time Frame: Post treatment at Month 1, Month 3, Month 6 ]
    Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.

  • Mean Pain Score Based on the Visual Analog Pain Scale [ Time Frame: Post treatment at Month 1, Month 3, Month 6 ]
    Mean pain score based on the Visual Analog pain scale. Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.


Enrollment: 20
Study Start Date: April 2013
Study Completion Date: January 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HET Arm
Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids
Device: HET Bipolar System
The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.

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 bipolar ligation of the superior hemorrhoidal blood supply.

Each prospective subject will be screened for inclusion and exclusion criteria at least one week prior to treatment. All patients undergoing treatment will review and sign the study Informed Consent prior to their procedure.

One to three internal hemorrhoids will be treated in one therapeutic session. The number will be based on the investigator's judgment of which quadrants are symptomatic. Evaluations will be recorded for all treated subjects immediately following treatment. Subjects will be followed at 1, 3, and 6 months post procedure unless complications are reported between scheduled follow-up dates. At each post treatment follow-up, a report will be made of pain/discomfort, bleeding, medication use, itching, presence of adverse events or complications and need for supplemental treatment. Face-to-face follow-up evaluations will include anoscopic evaluation and assessment of hemorrhoid and other relevant symptoms.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  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: NCT01841970

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Medtronic - MITG
  More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01841970     History of Changes
Other Study ID Numbers: HET-12-001
Study First Received: April 22, 2013
Results First Received: May 6, 2016
Last Updated: November 17, 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 July 21, 2017