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NCT03634306 · ClinicalTrials.gov registry record · NA
Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy
A NA study of Pain and Hysterectomy, sponsored by Mercy Research.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03634306: Completed NA study of Pain and Hysterectomy, sponsored by Mercy Research.
NCT03634306 is a NA study of Pain and Hysterectomy that has completed, run by Mercy Research. The registered enrollment target is 35 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03634306, a NA study of Pain and Hysterectomy, has completed, sponsored by Mercy Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective blinded, randomized controlled study. The study will include three study arms: Patients undergoing laparoscopic hysterectomies will be randomized to one of either "Ultravision" (study arm 1) or "no Ultravision" (study arm 2, i.e. the current standard of care) groups. The study will be conducted blinded to the investigator during the procedure through patient discharge. The Ultravision system will be present in both, with the generator covered (not seen by user) and either on or off depending on the randomization. 30 patients will be enrolled, 15 per group. Five patients undergoing myomectomy will have their procedures conducted using the Ultravision (study Arm 3). Ultravision is cleared for use in all laparoscopic surgery i.e. including laparoscopic hysterectomy and myomectomy, in the United States. However, the clinical benefits arising from its use in gynecology have not yet been quantitatively assessed and published in an independent medical journal. Study Purpose: There are three main study objectives 1. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on the quality of visualization in the laparoscopic field 2. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on procedural characteristics 3. To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on clinical outcomes.
Primary Outcome
Measure the quality of visualization in the laparoscopic field of view using a 5 point Visual Analog Scale. 0 is visible interference is imperceptible, 2-3 is perceptible to interfering, 4 is interfering, 5 is highly interfering)
Conditions Studied
Interventions
- DEVICE Ultravision System
- PROCEDURE Laparoscopic Hysterectomy
Study Locations (1)
Missouri
- Mercy Hospital St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2019-01-22 |
| Phase | NA |
What the finished NCT03634306 record still lists
NCT03634306 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 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Ultravision System is the first listed.
NCT03634306 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03634306 about?
NCT03634306 is a clinical study titled "Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy". This is a prospective blinded, randomized controlled study. The study will include three study arms: Patients undergoing laparoscopic hysterectomies will be randomized to one of either "Ultravision" (study arm 1) or "no Ultravision" (study arm 2, i.e. the current standard of care) groups. The study...
What is the current status of trial NCT03634306?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2018-10-11. Estimated completion is 2019-01-22.
What conditions does trial NCT03634306 study?
This clinical trial studies the following conditions: Pain, Hysterectomy, Myomectomy.
What interventions are being tested in trial NCT03634306?
The interventions under investigation include: Ultravision System (DEVICE), Laparoscopic Hysterectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03634306?
This trial is sponsored by Mercy Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03634306 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03634306's enrollment target sits among peer trials
35 299th of 374 higher than 74 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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.
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