Post-Market Study to Assess iTind Safety in Comparison to UroLift

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Olympus Corporation of the Americas
Study ID
NCT04757116
Status
Recruiting
Apply to this trial

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • iTind — DEVICE
    The iTind is implemented for 5-7 days
  • UroLift — PROCEDURE
    UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.

Study Details

The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.

Key Dates

First listed
Feb 17, 2021
Start date
Sep 26, 2022
Status verified
Jul 2026
Primary completion
Jul 15, 2027
Completion
May 31, 2030

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: iTind arm
    The iTind is a minimally invasive temporary implant
  • Active Comparator: UroLift
    The UroLift is a minimally invasive permanent implant

Primary Outcome Measure

Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months [ Time Frame: 3 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Rev Vilasan Shylaja
[email protected]
480-574-1466
Mitchell Humphreys, MD (PRINCIPAL_INVESTIGATOR)
Arizona Urology SpecialistsTucsonArizona85704-
Urology Associates of Central CaliforniaFresnoCalifornia93720
Joe Vidal
[email protected]
559-720-3646
William Schiff, MD (PRINCIPAL_INVESTIGATOR)
Golden State UrologySacramentoCalifornia95823
Sehaj Sethi
[email protected]
916-245-8888
Prithipal Sethi, MD (PRINCIPAL_INVESTIGATOR)
NorthShore University Health System Research InstituteEvanstonIllinois60201-
Southeast Louisiana Veterans Health Care SystemNew OrleansLouisiana70119
Kristen Lingle
[email protected]
504-507-2000
Louis Krane, MD (PRINCIPAL_INVESTIGATOR)
Minnesota UrologyWoodburyMinnesota55125
Melissa Robb
[email protected]
651-999-7033
Spencer Hart, MD (PRINCIPAL_INVESTIGATOR)
The Urology CenterOmahaNebraska68124
Amy Nelson
[email protected]
402-397-7989
Sida Niu, MD (PRINCIPAL_INVESTIGATOR)
Pacific West UrologyLas VegasNevada89121
John Dull
[email protected]
702-321-8045
Joel Abbott, MD (PRINCIPAL_INVESTIGATOR)
Feinstein Institutes for Medical Research / Northwell HealthSyossetNew York11791
Jennifer Polo
[email protected]
516-628-5926
Bilal Chughtai, MD (PRINCIPAL_INVESTIGATOR)
The Conrad Pearson ClinicGermantownTennessee38138
Russell Grigsby
[email protected]
731-377-9461
Adam Stewart, MD (PRINCIPAL_INVESTIGATOR)
Midtown Urology AssociatesAustinTexas78705
Andrew Barger
[email protected]
512-451-7935
Tyler McClintock, MD (PRINCIPAL_INVESTIGATOR)
Houston Metro UrologyHoustonTexas77027
Lena Ellis
[email protected]
713-634-4405
Mark Sutton, MD (PRINCIPAL_INVESTIGATOR)
The Urology PlaceSan AntonioTexas78240
Raji Thiruppathiraj
[email protected]
210-617-3670
Naveen Kella, MD (PRINCIPAL_INVESTIGATOR)
Potomac Urology CenterAlexandriaVirginia22311
Chamin Lim
[email protected]
703-680-2111
Nilay Gandhi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZArizona Urology Specialists· Tucson, AZUrology Associates of Central California· Fresno, CAGolden State Urology· Sacramento, CANorthShore University Health System Research Institute· Evanston, ILSoutheast Louisiana Veterans Health Care System· New Orleans, LA

Related Studies