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

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ClinicalTrials.gov Identifier: NCT01841970
Recruitment Status : Completed
First Posted : April 29, 2013
Results First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

April 22, 2013
April 29, 2013
May 6, 2016
January 16, 2017
January 16, 2017
April 2013
November 2014   (Final data collection date for primary outcome measure)
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
Change in hemorrhoid condition and stage [ Time Frame: Post-treatment (immediately), month1, month 3, months 6 ]
Hemorrhoid condition and stage will be assessed by patient history and anoscopic evaluation
Complete list of historical versions of study NCT01841970 on ClinicalTrials.gov Archive Site
  • 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.
  • Incidence of Recurrence of Pre-procedure Symptoms [ Time Frame: Month 1, month 3, and month 6 ]
    Recurrence of pre-procedure symptoms after initial improvement
  • Safety assessment based on the number of adverse events and complications [ Time Frame: Post-treatment (immediately), month 1, month 3, month 6 ]
  • Pain assessment based on the Visual Analog Pain Scale [ Time Frame: Post-treatment (immediately), month 1, month 3, month 6 ]
    Patient will record pain level daily until pain is resolved
Not Provided
Not Provided
 
Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemorrhoids, Internal
Device: HET Bipolar System
The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.
HET Arm
Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids
Intervention: Device: HET Bipolar System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
100
January 2015
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01841970
HET-12-001
No
Not Provided
Not Provided
Medtronic - MITG
Medtronic - MITG
Not Provided
Not Provided
Medtronic - MITG
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP