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

November 17, 2016 updated by: Medtronic - MITG

Multi-Center, Prospective Study of the Safety and Efficacy of the HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post treatment at Month1, Month 3, Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post treatment at Month 1, Month 3, and Month 6
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.
Post treatment at Month 1, Month 3, Month 6
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.
Post treatment at Month 1, Month 3, Month 6
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.
Post treatment at Month 1, Month 3, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (ESTIMATE)

April 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2017

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HET-12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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