N/A
N=35
Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy
Pain · Hysterectomy · Myomectomy
Bottom Line
View on ClinicalTrials.gov: NCT03634306 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Quality of Surgical Field Visualization — 9; 1; 5; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultravision System (Device); Laparoscopic Hysterectomy (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Mercy Research
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Surgical Field Visualization |
9; 1; 5; 2; 2; 0 | — |
| PRIMARY Consumed CO2 |
16.7; 23.5; 25.7 | — |
| SECONDARY Operative Procedure Disruption |
1.6; 3.6; 0 | — |
| SECONDARY Intra-abdominal Pressure |
10.7; 12.3; 10 | — |
| SECONDARY Number of Participants With Adjusted Intra-abdominal Pressure |
2; 7; 0 | — |
| SECONDARY Duration of Intra-abdominal Pressure Increase |
31.5; 59.8; 0 | — |
| SECONDARY Temperature at Time 0 Min |
35.93; 35.75; 35.96 | — |
| SECONDARY Temperature at Time 15 Min |
35.93; 35.87; 36.14 | — |
| SECONDARY Temperature at Time 30 Min |
35.99; 35.93; 36.18 | — |
| SECONDARY Temperature at Time 45 Min |
36.03; 36.09; 36.42 | — |
| SECONDARY Temperature at Time 60 Min |
36.19; 36.05; 36.20 | — |
| SECONDARY End-Tidal CO2 Level at Time 0 |
35.4; 35.1; 33.6 | — |
| SECONDARY End-Tidal CO2 Level at Time 15 |
35.7; 36.1; 34.2 | — |
| SECONDARY End-Tidal CO2 Level at Time 30 |
35.1; 35.8; 34.0 | — |
| SECONDARY End-Tidal CO2 Level at Time 45 |
35.9; 35.4; 35.4 | — |
| SECONDARY End-Tidal CO2 Level at Time 60 |
36.1; 35.0; 35.8 | — |
| SECONDARY Duration of Procedure |
40.5; 46.9; 56.8 | — |
| SECONDARY Number of Participants With a Hospital Stay Less Than 24 Hours |
15; 15; 5 | — |
| SECONDARY Postoperative Pain Numerical Rating Scale |
0.7; 0.1; 0 | — |
| SECONDARY Postoperative Pain Numerical Rating Scale |
0.7; 0.1; 0 | — |
| SECONDARY Number of Participants That Received Post-operative Opioid Pain Medication |
12; 12; 5 | — |
| SECONDARY Number of Participants That Received Post-operative Non-opioid Pain Medication |
14; 14; 5 | — |
| SECONDARY Number of Participants Reporting Opioid Pain Medication Use at Follow up |
10; 7; 5 | — |
| SECONDARY Number of Participants Reporting Non-opioid Pain Medication Use at Follow up |
10; 9; 1 | — |
| SECONDARY Adverse Events Related to Procedure |
5; 2; 0 | — |
| SECONDARY Adverse Events Related to Smoke Clearing Device |
0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
- Subjects MUST not have any of the following:
- Existing comorbidities that would contraindicate them for laparoscopic surgery.
- Be pregnant.
Data sourced from ClinicalTrials.gov (NCT03634306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.