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NCT03956082 · ClinicalTrials.gov registry record · NA
Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for Endometriosis
A NA study, sponsored by Mercy Research.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT03956082 is a NA study that has completed, run by Mercy Research. The registered enrollment target is 15 participants.
The verdict
NCT03956082, a NA study, has completed, sponsored by Mercy Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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).
Interventions
- DEVICE Ultravision™ Visual Field Clearing System
- DEVICE Ultravision Ionwand™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-08-07 |
| Est. Completion | 2021-04-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03956082
The ClinicalTrials.gov registry entry for NCT03956082 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mercy Research, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ultravision™ Visual Field Clearing System is the first listed.
NCT03956082 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03956082 about?
NCT03956082 is a clinical study titled "Ultravision™ System to Facilitate Low Impact Laparoscopic Surgery for Endometriosis". 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. Pat...
What is the current status of trial NCT03956082?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2019-08-07. Estimated completion is 2021-04-14.
What interventions are being tested in trial NCT03956082?
The interventions under investigation include: Ultravision™ Visual Field Clearing System (DEVICE), Ultravision Ionwand™ (DEVICE).
Who is sponsoring clinical trial NCT03956082?
This trial is sponsored by Mercy Research, which has 14 total clinical trials registered on ClinicalTrials.gov.
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