Health TrialsbyHealthPanel

Moses 2.0 vs Magneto for HoLEP - a Randomized Controlled Trial

ConditionsEnlarged Prostate (BPH)Benign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-100
SponsorNorthwestern University

About this trial

The objective of this study is to compare the Magneto 150 holmium laser to the current MOSES 2.0 technology to see if there is a benefit in decreased hemostasis time intraoperatively.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms

Internet access and a device to complete postoperative questionnaires (smartphone, tablet, laptop or desktop computer)

Disqualifiers

Patients who lack decisional capacity

Patients unable to read/speak English

Patients who are on a blood thinner (anticoagulation medication)

Patients who do not have internet access to complete postoperative surveys

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magneto 150 holmium laser

    Device

    The HoLEP procedure will be performed using the Quanta Magneto 150 holmium laser

  • Moses 2.0 holmium laser

    Device

    The HoLEP procedure will be performed using the Moses 2.0 holmium laser

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Moses 2.0Active comparator 1 intervention
Group B: Magneto 150Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean hemostasis time

Overall intraoperative hemostasis time

Time frame
During surgery

Secondary outcomes

1

Mean (average) enucleation time

Time taken to surgically remove excess prostate tissue while leaving the shell of the prostate intact and within the body.

Time frame
During surgery
2

Total operative time

Time taken from official procedure start to completion (not accounting for the time that the patient is wheeled in, prepped and out of the operating room).

Time frame
During surgery
3

Hemostasis efficiency

minutes/gram (prostate tissue removed)

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Cook Group Incorporated

Collaborator

Source ClinicalTrials.gov
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