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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
HET Arm	HET Bipolar System	Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids

Primary Outcome Measures

Name	Time	Method
Number of Participants With Resolution of Symptoms	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

Name	Time	Method
Recurrence of Symptoms That Had Resolved With Treatment	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.
Incidence of Recurrence of Pre-procedure Symptoms	Post treatment at Month 1, Month 3, and Month 6	Recurrence of pre-procedure symptoms after initial improvement
Mean Pain Score Based on the Visual Analog Pain Scale	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.
Pain Recorded Yes or No on Visual Analog Scale (VAS)	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.