Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for Endometriosis

NCT03956082 | Completed Results FDA Device

• 1 other identifier: 19-109
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 1.Demonstrate the feasibility of undertaking low impact laparoscopic surgery for endometriosis when using the Ultravision™ System.
2. 2.Assess the impact of Ultravision on visual field clarity.
3. 3.Determine the ability to complete the procedure while maintaining an abdominal pressure of \< 10mmHg.
4. 4.Quantify the consumption of CO2.
5. 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

Outcome Measures

Primary Outcomes (2)

• Procedure Completed Without Change in Intra-abdominal Pressure

  The ability to complete the procedure without increasing pneumoperitoneum due to visualization. Any increase beyond 10mm Hg and the reason for change will be recorded.

  Intraoperative

• Quality of Visualization Laparoscopic Field

  The quality of visualization in the laparoscopic field of view will be assessed by the investigator using a Visual Analog Scale (VAS). The scale will rate the overall quality of visualization during the procedure on a scale numbered 0 to 100, in increments of 10, where 0 equals poor and 100 equals excellent.

  Intra-operative

Secondary Outcomes (5)

• Cosmesis Outcome

  A mean of 31 days (SD=2.8) after surgical procedure

• Postoperative Shoulder Pain Assessment (Day 1-7)

  Day 1-7 postoperative

• Opioid/Opioid-containing Medication Taken Postoperatively for Pain

  Day 1-7 postoperative

• Postoperative Abdominal Pain Assessment (Day 1-7)

  Day 1-7 postoperative

• Non-opioid Medication Taken Postoperatively for Pain

  Day 1-7 postoperative

Other Outcomes (2)

• End Tidal CO2 Volume

  Intraoperative

• Case Complexity

  End of procedure

Study Arms (1)

This is a prospective single arm study

OTHER

The Ultravision™ System is an FDA-cleared medical device that removes surgical smoke by means of electrostatic precipitation from the visual field during laparoscopic surgical procedures. "Surgical smoke" refers to the suspended particulate matter that is generated as a by-product of the combustion and other processes that are associated with the use of energy-based surgical instruments.

Device: Ultravision™ Visual Field Clearing System; Device: Ultravision Ionwand™

Interventions

Ultravision™ Visual Field Clearing 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

This is a prospective single arm study

Ultravision Ionwand™ DEVICE

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.

This is a prospective single arm study

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will enroll female patients who are indicated for laparoscopic surgery for the treatment of endometriosis
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects MUST meet all the following:
• Is 18 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 indicated for laparoscopic surgery for the treatment of endometriosis.
• Able to read and understand English.

You may not qualify if:

• Subjects MUST not have any of the following:
• Existing comorbidities that would contraindicate them for laparoscopic surgery.
• Patient anatomy that is not compatible with the use of the Ionwand catheter i.e. abdominal wall thickness that exceeds the working length of the Ionwand catheter identified intraoperatively
• Patient with a BMI \> 50
• Be pregnant

Sponsors & Collaborators

• Mercy Research: lead

Study Sites (1)

Minimally Invasive Gynecology, Mercy Hospital St Louis

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

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

DAVID.LEVINE@MERCY.NET

314-251-7650

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: A sample size of 20 patients should provide a sufficient sample size for comparative analysis to prior clinical data relative to Ultravision and published peer reviewed clinical data on laparoscopy and low impact laparoscopy
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Minimally Invasive Gynecology

Model Details: 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. Duration of Study: The target for the overall duration of the study is four months

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: August 7, 2019
• Primary Completion: April 14, 2021
• Study Completion: April 14, 2021
• Last Updated: November 17, 2022
• Results First Posted: November 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)