Application of MOSES Technology in BPH | NCT04648176

Studies
Application of MOSES Technology in BPH

NCT04648176

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Unknown status

Last Update Posted

Dec 1, 2020Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms

Interventions

Moses technology

Countries

Spain

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2020Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Mar 6, 2020

First Submission Date that Met QC Criteria

Nov 27, 2020

First Posted Date

Dec 1, 2020Actual

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

Nov 27, 2020

Last Update Posted Date

Dec 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.

Detailed Description

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HoLEP	Active Comparator	Conventional laser	Device: Moses technology
m-HoLEP	Experimental	Moses technology	Device: Moses technology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moses technology	Device	Using Holmium laser with Moses technology or conventional one	HoLEP m-HoLEP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin	Hemoglobin change	24 hours after the surgery

Secondary Outcomes

Measure	Description	Time Frame
Enucleation time	Enucleation time change	during the surgery
Hemostasis time	Hemostasis time change	during the surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prostatic volume between 70-200cc
Acceptance to participate in the study.

Exclusion Criteria:

Previous urethra stricture
Previous prostate surgery
Neurogenic bladder
Bladder tumor
Neurological disease with repercussion in the lower urinary tract.
Severe psychiatric illness
Inability of the patient to consent

Accepts Healthy Volunteers

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
Adrià Piñero Zomeño, MD	Contact	934893000	6370	adria.pinero@gmail.com

Overall Officials

Name	Affiliation	Role
José Placer Santos, PhD	Vall d'Hebrón University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vall d'Hebron University Hospital	Recruiting	Barcelona		08035	Spain

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
D059411	Lower Urinary Tract Symptoms

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