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

Hemorrhoids, Internal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841970
• Other study ID #: HET-12-001
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: June 1, 2015
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Hemorrhoids, Internal

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemorrhoid condition and stage	Hemorrhoid condition and stage will be assessed by patient history and anoscopic evaluation	Post-treatment (immediately), month1, month 3, months 6	No
Secondary	Incidence of recurrence of pre-procedure symptoms	Recurrence of pre-procedure symptoms after initial improvement	Month 1, month 3, and month 6	No
Secondary	Safety assessment based on the number of adverse events and complications		Post-treatment (immediately), month 1, month 3, month 6	Yes
Secondary	Pain assessment based on the Visual Analog Pain Scale	Patient will record pain level daily until pain is resolved	Post-treatment (immediately), month 1, month 3, month 6	No