N/A
N=20
Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
Hemorrhoids, Internal
Bottom Line
View on ClinicalTrials.gov: NCT01841970 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Participants With Resolution of Symptoms — 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HET Bipolar System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Resolution of Symptoms |
18 | — |
| SECONDARY Incidence of Recurrence of Pre-procedure Symptoms |
0; 3; 4; 18; 8; 5 | — |
| SECONDARY Recurrence of Symptoms That Had Resolved With Treatment |
18; 11; 9; 0; 0; 0 | — |
| SECONDARY Pain Recorded Yes or No on Visual Analog Scale (VAS) |
4; 1; 1; 14; 10; 8 | — |
| SECONDARY Mean Pain Score Based on the Visual Analog Pain Scale |
0.7; 0.4; 0.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01841970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.