Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy

NCT03634306 | Completed Results FDA Device

• 1 other identifier: 18-091
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on procedural characteristics
3. 3.To evaluate the impact of use of Ultravision device during laparoscopic hysterectomy and myomectomy on clinical outcomes.

Conditions

Pain; Hysterectomy; Myomectomy

Keywords

Visual clearing System Laparoscopic Hysterectomy Myomectomy

Outcome Measures

Primary Outcomes (2)

• Quality of Surgical Field Visualization

  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)

  End of procedure

• Consumed CO2

  Amount of CO2 Consumed in liters from placement of all surgical ports to colpotomy (hysterectomy) or closure of last uterine defect (myomectomy)

  End of procedure

Secondary Outcomes (24)

• Operative Procedure Disruption

  Intraoperative

• Intra-abdominal Pressure

  End of procedure

• Number of Participants With Adjusted Intra-abdominal Pressure

  Intraoperative

• Duration of Intra-abdominal Pressure Increase

  Intraoperative

• Temperature at Time 0 Min

  Intraoperative

Study Arms (3)

ARM 1

ACTIVE COMPARATOR

Laparoscopic hysterectomy with use of the Ultravision System

Device: Ultravision System

ARM 2

PLACEBO COMPARATOR

Laparoscopic Hysterectomy per Standard of Care/no Ultravision System

Procedure: Laparoscopic Hysterectomy

ARM 3

ACTIVE COMPARATOR

Laparoscopic myomectomy with use of the Ultravision System.

Device: Ultravision System

Interventions

Ultravision System DEVICE

Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.

ARM 1; ARM 3

Laparoscopic Hysterectomy PROCEDURE

Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System

ARM 2

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: The study will enroll female patients who are indicated for laparoscopic hysterectomy or myomectomy.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Levine, MD
• Organization: Mercy Hospital St. Louis

David.Levine@Mercy.net

314-251-7650

Study Officials

• David J Levine, MD

  Mercy Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients will be randomized using a paper envelope system, just prior to surgery. Investigator will not be informed of the randomization assignment until after the patient is discharged (end of follow-up period). A simple envelope system is used. Pre-made study arm assignment envelopes will be created. Envelopes will be opened just prior to the procedure. For patients randomized \& withdrawn prior to the procedure or converted to open procedure, replacement envelopes will be added to the envelope pool. To preserve blinding during the procedure, the Ultravision System consumable will be introduced into the patient, generator will appear operational during all procedures. The display will be covered during use so the investigator is not aware the system is on/off. If for any reason un blinding occurs, the reason will be recorded. Study assessments will be collected per protocol, but the data will not be pooled with blinded data for analysis.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Minimally Invasive Gynecology

Model Details: STUDY DESIGN This is a prospective blinded, randomized controlled study. Arms 1 and 2: Patients enrolling in study arms 1 and 2 who are undergoing hysterectomy will be randomized to either the Ultravision™ System (Arm 1) or Standard of Care/no Ultravision (Arm 2) study arms. Arm 3: Patients enrolling in study arm 3 who are undergoing a myomectomy will have their procedure conducted with the Ultravision™ System. The procedure is purported to generate the greatest smoke and therefore constitutes a worst-case challenge for the system. All prescribed evaluations will be performed for all study arms. STUDY SIZE Arms 1 and 2 (randomized) will enroll 15 patients each. Arm 3 will enroll an additional 5 patients. DURATION The total duration of the study is expected to be approximately 6 months.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 16, 2018
• Study Start: October 11, 2018
• Primary Completion: December 21, 2018
• Study Completion: January 22, 2019
• Last Updated: March 10, 2020
• Results First Posted: January 29, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)