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NCT02773420 · ClinicalTrials.gov registry record · NA
HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment
A NA study of Hemorrhoids, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT02773420: Completed NA study of Hemorrhoids, sponsored by University of Illinois at Chicago.
NCT02773420 is a NA study of Hemorrhoids that has completed, run by University of Illinois at Chicago. The registered enrollment target is 35 participants, below the 80-participant average among 3 other Hemorrhoids trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02773420, a NA study of Hemorrhoids, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients previously. Methods: Patients seen at a colorectal clinic in a single institution with grade I-II hemorrhoids are offered to participate in a prospective pilot trial. The HET device is a modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of hemorrhoids are treated with 2 heat energy applications per column. The primary outcome is the treatment effect on hemorrhoid symptoms of bleeding, pain, prolapse, itching, and soiling. This is measured with a patient completed questionnaire documenting each symptom's frequency from 0 to 3 (i.e. 0 is \< 1x/month; 3 is daily) before therapy and at 3 weeks and 6 month follow-up. Post-treatment pain scores were recorded using the visual analog scale (VAS).
Primary Outcome
The effect of HET on symptoms of bleeding, pain, prolapse, itching, and soiling.
Conditions Studied
Interventions
- PROCEDURE HET Application
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-08 |
| Est. Completion | 2019-01 |
| Phase | NA |
What the finished NCT02773420 record still lists
NCT02773420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 80-participant average among 3 other Hemorrhoids trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Hemorrhoids appearing as the primary indexed condition, and to 1 intervention - of which HET Application is the first listed.
NCT02773420 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02773420 about?
NCT02773420 is a clinical study titled "HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment". Purpose: The current study aims to evaluate the safety and effectiveness of the HET™ Bipolar System (Medtronic, Boulder, CO) for the treatment of grade I-II hemorrhoids in a prospective pilot study. This device was evaluated retrospectively in a limited cohort of 23 patients previously. Methods: Pa...
What is the current status of trial NCT02773420?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2015-08. Estimated completion is 2019-01.
What conditions does trial NCT02773420 study?
This clinical trial studies the following conditions: Hemorrhoids.
What interventions are being tested in trial NCT02773420?
The interventions under investigation include: HET Application (PROCEDURE).
Who is sponsoring clinical trial NCT02773420?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02773420 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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