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Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for Endometriosis

NCT03956082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-11-17

Study results available
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Summary

This is a prospective single arm study. The study will enroll 20 patients. Comparisons to prior clinical trials and published literature will be made to assess the relative significance of the study results.The study will enroll patients indicated for laparoscopic surgery to treat endometriosis. Patients must meet all inclusion/exclusion criteria.

There are five main study objectives:

1. Demonstrate the feasibility of undertaking low impact laparoscopic surgery for endometriosis when using the Ultravision™ System.
2. Assess the impact of Ultravision on visual field clarity.
3. Determine the ability to complete the procedure while maintaining an abdominal pressure of \< 10mmHg.
4. Quantify the consumption of CO2.
5. Collect data on additional clinical outcomes associated with the use of Ultravision and low impact surgery (i.e. end tidal CO2 levels (EtCO2), adverse events, cosmesis outcome, postoperative pain levels and pain medications).

Conditions

  • Endometriosis

Interventions

DEVICE

Ultravision™ Visual Field Clearing System

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

DEVICE

Ultravision Ionwand™

The Ionwand™ is introduced into the abdomen through either the Ultravision™ 5mm Trocar or a 2.5 mm percutaneous catheter. The Ionwand™ provides the source of electrons that create the negative ions that transiently charge the surgical smoke particles and accelerate their sedimentation.

Sponsors & Collaborators

  • Mercy Research

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2021-04-14
Completion
2021-04-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03956082 on ClinicalTrials.gov