Skip to main content
OpenTrials
Completed

NCT Number: NCT01841970

Safety and Efficacy Study of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemorrhoids, Internal Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HET Bipolar System

Device

The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 29, 2013
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.