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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemorrhoids, Internal

Intervention / Treatment
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* Device: HET Bipolar System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HET Arm<br>Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids | Device: HET Bipolar System<br>* The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Resolution of Symptoms | 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 | 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 | 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) | 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 | 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 |