Moses 2.0 vs Magneto for HoLEP - a Randomized Controlled... | NCT07632742

Studies
Moses 2.0 vs Magneto for HoLEP - a Randomized Controlled Trial

NCT07632742

Sponsor

Northwestern University

Status

Recruiting

Last Update Posted

Jun 8, 2026Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Enlarged Prostate (BPH)
Benign Prostatic Hyperplasia

Interventions

Magneto 150 holmium laser
Moses 2.0 holmium laser

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Jun 2, 2026

First Submission Date that Met QC Criteria

Jun 5, 2026

First Posted Date

Jun 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2026

Last Update Posted Date

Jun 8, 2026Actual

Name	Class
Cook Group Incorporated	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

The Magneto 150 is a high-powered 150W holmium laser that offers similar pulse-modulation benefits of MOSES 2.0, which facilitates effective dissection and enucleation of the tissue plane while also offering a new first-of-its kind proprietary Magneto setting which allows for very low peak power of 500W and longer pulse duration which allows for better hemostasis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moses 2.0	Active Comparator	HoLEP procedure performed using the Moses 2.0 holmium laser	Device: Moses 2.0 holmium laser
Magneto 150	Experimental	HoLEP procedure performed using Magneto 150 holmium laser	Device: Magneto 150 holmium laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magneto 150 holmium laser	Device	The HoLEP procedure will be performed using the Quanta Magneto 150 holmium laser	Magneto 150

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean hemostasis time	Overall intraoperative hemostasis time	During surgery

Secondary Outcomes

Measure	Description	Time Frame
Mean (average) enucleation time	Time taken to surgically remove excess prostate tissue while leaving the shell of the prostate intact and within the body.	During surgery
Total operative time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alyssa McDonald, MPH	Contact	312-695-8146		alyssa.mcdonald@northwestern.edu

Overall Officials

Name	Affiliation	Role
Perry Xu, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University	Recruiting	Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Participants will be randomized to undergo HoLEP with their surgeon using the MOSES 2.0 holmium laser or the Magneto 150 holmium laser. Participants will not know their randomization prior to procedure, but they will be able to find out at any time after the HoLEP procedure.

Who Masked

Not provided