Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy

Completed · Not applicable

Conditions studied: Pain, Hysterectomy, Myomectomy

In brief

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.

Key facts

Study ID

NCT03634306

Run by

Mercy Research

People needed

35

Starts

2018-10-11

Expected to finish

2019-01-22

Last updated by the study team

2020-03-10

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Subjects MUST meet all the following:
• Is 21 years or older.
• Provide written informed consent prior to trial procedures after studies indicate that the patient needs the prescribed procedure.
• Agrees to attend all follow-up assessments.
• Is clinically indicated to undergo laparoscopic hysterectomy or myomectomy.

You may not qualify if…

• Subjects MUST not have any of the following:
• Existing comorbidities that would contraindicate them for laparoscopic surgery.
• Be pregnant.

Where it is running

• Mercy Hospital St. Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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