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NCT01841970 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
A NA study, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01841970: Completed NA study, sponsored by Medtronic - MITG.
NCT01841970 is a NA study that has completed, run by Medtronic - MITG. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01841970, a NA study, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment
Interventions
- DEVICE HET Bipolar System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-01 |
| Phase | NA |
What the finished NCT01841970 record still lists
NCT01841970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which HET Bipolar System is the first listed.
NCT01841970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01841970 about?
NCT01841970 is a clinical study titled "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 Hem...
What is the current status of trial NCT01841970?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01841970?
The interventions under investigation include: HET Bipolar System (DEVICE).
Who is sponsoring clinical trial NCT01841970?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01841970's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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