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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03634306
The ClinicalTrials.gov registry entry for NCT03634306 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (88% lower). The listed sponsor is Mercy Research, which has 14 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Related
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