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NCT04826887 · ClinicalTrials.gov registry record
SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia
A clinical trial, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- 15
- Enrollment target
NCT04826887: Completed study, sponsored by University of Kansas Medical Center.
NCT04826887 is a clinical trial that has completed, run by University of Kansas Medical Center. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04826887 has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate. Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations
Primary Outcome
To evaluate SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) in comparison to Holmium Laser Enucleation of the Prostate through AUA Symptom Score. AUA Symptom score will be assessed using the Scale - Mild (under 7 cumulative score, moderate 8-19 score, and severe is a cumulative score over 20).
Interventions
- OTHER SOLTIVE Thulium Laser
- OTHER Standard of Care (Holmium Laser)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2024-05-02 |
What the finished NCT04826887 record still lists
NCT04826887 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which SOLTIVE Thulium Laser is the first listed.
NCT04826887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04826887 about?
NCT04826887 is a clinical study titled "SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia". To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate. Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient proce...
What is the current status of trial NCT04826887?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2021-04-14. Estimated completion is 2024-05-02.
What interventions are being tested in trial NCT04826887?
The interventions under investigation include: SOLTIVE Thulium Laser (OTHER), Standard of Care (Holmium Laser) (OTHER).
Who is sponsoring clinical trial NCT04826887?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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