18 and older, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Procedure Completed Without Change in Intra-abdominal PressurePrimary· Intraoperative
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.
Group
Value
95% CI
This is a Prospective Single Arm Study
9
Quality of Visualization Laparoscopic FieldPrimary· Intra-operative
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.
Group
Value
95% CI
This is a Prospective Single Arm Study
100
± 0
Cosmesis OutcomeSecondary· A mean of 31 days (SD=2.8) after surgical procedure
Patient satisfaction in post-surgical cosmesis outcome, administered via telephone, assessed by means of a survey scaled from 1 - 7, where 1 = "very unsatisfied" and 7 = "very satisfied".
5
Group
Value
95% CI
This is a Prospective Single Arm Study
1
6
Group
Value
95% CI
This is a Prospective Single Arm Study
2
7
Group
Value
95% CI
This is a Prospective Single Arm Study
6
Postoperative Shoulder Pain Assessment (Day 1-7)Secondary· Day 1-7 postoperative
Patient shoulder postoperative pain assessments. Recorded by the patient each day from day 1 to day 7 postoperative using a 10 Numerical Rating Scale (NRS) where 0 is "no pain at all" to 10 "worst pain imaginable".
Post-operative day 1
Group
Value
95% CI
This is a Prospective Single Arm Study
3.125
0 – 7
Post-operative day 2
Group
Value
95% CI
This is a Prospective Single Arm Study
1.25
0 – 5
Post-operative day 3
Group
Value
95% CI
This is a Prospective Single Arm Study
0.5
0 – 2
Post-operative day 4
Group
Value
95% CI
This is a Prospective Single Arm Study
0.625
0 – 3
Post-operative day 5
Group
Value
95% CI
This is a Prospective Single Arm Study
0.25
0 – 2
Post-operative day 6.
Group
Value
95% CI
This is a Prospective Single Arm Study
0.125
0 – 1
Post-operative day 7
Group
Value
95% CI
This is a Prospective Single Arm Study
0
0 – 0
Opioid/Opioid-containing Medication Taken Postoperatively for PainSecondary· Day 1-7 postoperative
Some subjects recorded taking opioid and non-opioid medications for pain. Non-opioid medications included non-steroidal anti-inflammatory drugs and acetaminophen.
Post-operative day 1
Group
Value
95% CI
This is a Prospective Single Arm Study
5
Post-operative day 2
Group
Value
95% CI
This is a Prospective Single Arm Study
3
Post-operative day 3
Group
Value
95% CI
This is a Prospective Single Arm Study
0
Post-operative day 4
Group
Value
95% CI
This is a Prospective Single Arm Study
0
Post-operative day 5
Group
Value
95% CI
This is a Prospective Single Arm Study
0
Post-operative day 6
Group
Value
95% CI
This is a Prospective Single Arm Study
0
Post-operative day 7
Group
Value
95% CI
This is a Prospective Single Arm Study
1
End Tidal CO2 VolumeSecondary· Intraoperative
End tidal CO2 volume (etCO2) taken at the start of the procedure and at the end of the procedure (trocar removal).
At the beginning of the procedure.
Group
Value
95% CI
This is a Prospective Single Arm Study
32.1
± 3.1
At the end of the procedure.
Group
Value
95% CI
This is a Prospective Single Arm Study
35.2
± 2.4
Case ComplexitySecondary· End of procedure
Estimate of case complexity/difficulty will be recorded using a Visual Analog Scale (VAS) indicating how often smoke management was a factor during the procedure on a scale ranging from 1 - 100, where 1 was "Often" and 100 was "Never".
Group
Value
95% CI
This is a Prospective Single Arm Study
100
± 0
Postoperative Abdominal Pain Assessment (Day 1-7)Secondary· Day 1-7 postoperative
Patient postoperative abdominal pain assessments. Recorded by the patient each day from day 1 to day 7 postoperative using a 10 Numerical Rating Scale (NRS) where 0 is "no pain at all" to 10 "worst pain imaginable".
Post-operative day 1
Group
Value
95% CI
This is a Prospective Single Arm Study
3.125
0 – 6
Post-operative day 2
Group
Value
95% CI
This is a Prospective Single Arm Study
3.75
1 – 6
Post-operative day 3
Group
Value
95% CI
This is a Prospective Single Arm Study
3
1 – 5
Post-operative day 4
Group
Value
95% CI
This is a Prospective Single Arm Study
2.75
1 – 6
Post-operative day 5
Group
Value
95% CI
This is a Prospective Single Arm Study
2.25
1 – 4
Post-operative day 6
Group
Value
95% CI
This is a Prospective Single Arm Study
1.6875
0 – 7.5
Post-operative day 7
Group
Value
95% CI
This is a Prospective Single Arm Study
1.375
0 – 3
Non-opioid Medication Taken Postoperatively for PainSecondary· Day 1-7 postoperative
Some subjects recorded taking opioid and non-opioid medications for pain. Non-opioid medications included non-steroidal anti-inflammatory drugs and acetaminophen.
Post-operative day 1
Group
Value
95% CI
This is a Prospective Single Arm Study
6
Post-operative day 2
Group
Value
95% CI
This is a Prospective Single Arm Study
7
Post-operative day 3
Group
Value
95% CI
This is a Prospective Single Arm Study
5
Post-operative day 4
Group
Value
95% CI
This is a Prospective Single Arm Study
6
Post-operative day 5
Group
Value
95% CI
This is a Prospective Single Arm Study
4
Post-operative day 6
Group
Value
95% CI
This is a Prospective Single Arm Study
3
Post-operative day 7
Group
Value
95% CI
This is a Prospective Single Arm Study
3
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mercy Research
Last refreshed: 17 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03956082.