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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in hemorrhoid condition and stage [ Time Frame: Post-treatment (immediately), month1, month 3, months 6 ] [ Designated as safety issue: No ]Hemorrhoid condition and stage will be assessed by patient history and anoscopic evaluation
- Incidence of recurrence of pre-procedure symptoms [ Time Frame: Month 1, month 3, and month 6 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- Pain assessment based on the Visual Analog Pain Scale [ Time Frame: Post-treatment (immediately), month 1, month 3, month 6 ] [ Designated as safety issue: No ]Patient will record pain level daily until pain is resolved
|Study Start Date:||April 2013|
|Study Completion Date:||January 2015|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Device: HET Bipolar System
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841970
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|