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NCT04963062 · ClinicalTrials.gov registry record · Phase 4
Moses vs. Thulium Laser Study
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
NCT04963062 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 114 participants.
The verdict
NCT04963062, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
Study Summary
The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe surgical treatment of stone disease. Over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. The holmium laser is considered the gold standard for laser lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment modalities for stone disease. Two in vitro studies have compared Moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with Moses, but no clinical trials have compared the two treatment modalities. In this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the Holmium laser with Moses and the thulium laser. This is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.
Interventions
- DEVICE Holmium laser with Moses lasers
- DEVICE Holmium laser with thulium lasers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04963062
The ClinicalTrials.gov registry entry for NCT04963062 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Holmium laser with Moses lasers is the first listed.
NCT04963062 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04963062 about?
NCT04963062 is a clinical study titled "Moses vs. Thulium Laser Study". The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe...
What is the current status of trial NCT04963062?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2021-07-16. Estimated completion is 2023-05-02.
What interventions are being tested in trial NCT04963062?
The interventions under investigation include: Holmium laser with Moses lasers (DEVICE), Holmium laser with thulium lasers (DEVICE).
Who is sponsoring clinical trial NCT04963062?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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