N/A
Completed N=15
Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for Endometriosis
Source: ClinicalTrials.gov NCT03956082 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Procedure Completed Without Change in Intra-abdominal Pressure — 9 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Completed Without Change in Intra-abdominal Pressure |
9 | — |
| PRIMARY Quality of Visualization Laparoscopic Field |
100 | — |
| SECONDARY Cosmesis Outcome |
1; 2; 6 | — |
| SECONDARY Postoperative Shoulder Pain Assessment (Day 1-7) |
3.125; 1.25; 0.5; 0.625; 0.25; 0.125 | — |
| SECONDARY Opioid/Opioid-containing Medication Taken Postoperatively for Pain |
5; 3; 0; 0; 0; 0 | — |
| SECONDARY Postoperative Abdominal Pain Assessment (Day 1-7) |
3.125; 3.75; 3; 2.75; 2.25; 1.6875 | — |
| SECONDARY Non-opioid Medication Taken Postoperatively for Pain |
6; 7; 5; 6; 4; 3 | — |
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT03956082). 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. Informational only — not medical advice.