Desara ® One Single Incision Sling 522 Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Caldera Medical, Inc.
Study ID
NCT04772131
Status
Recruiting
Apply to this trial

Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Desara® One Single Incision Sling — DEVICE
    Single incision sling
  • Desara® Blue Transobturator Sling — DEVICE
    Standard mid-urethral sling

Study Details

A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.

Key Dates

Start date
Nov 1, 2021
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Desara® One
    Single Incision Sling
  • Active Comparator: Desara® Blue
    Transobturator Sling

Primary Outcome Measure

Success rate of negative standing cough stress test (CST) [ Time Frame: 36 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Valley Urogynecology Associates, Inc.PhoenixArizona85016
Dawn Hill
[email protected]
(602) 788-1521
Mirna Lopez
[email protected]
Shazia Malik, MD (PRINCIPAL_INVESTIGATOR)
University of Arizona College of MedicineTucsonArizona85724
Shaman Hashim
[email protected]
520-626-5935
llana Addis, MD (PRINCIPAL_INVESTIGATOR)
Urological Research Center CorpHialeahFlorida33016
Isabel Lopez
[email protected]
786-431-2014
Edward L Gheiler, MD (PRINCIPAL_INVESTIGATOR)
Women's Health Care Associates P.A. dba Rosemark Women Care SpecialistsIdaho FallsIdaho83404
Sydney Nelson
[email protected]
208-557-2924
Ty Erickson, MD (PRINCIPAL_INVESTIGATOR)
CMB Research, LLCNewburghIndiana47630
Laura Holder
[email protected]
812-853-3500
Cindy Basinski, MD (PRINCIPAL_INVESTIGATOR)
University of LouisvilleLouisvilleKentucky40202
Gena Sayat, LPN
502-588-4400
Sean Francis, MD (PRINCIPAL_INVESTIGATOR)
Mt. Auburn Hospital Division of UrogynecologyCambridgeMassachusetts02138
Kathleen Rogers
[email protected]
617-354-5452
Peter Rosenblatt, MD (PRINCIPAL_INVESTIGATOR)
Specialty Clinical Research of St. Louis, LLCSt LouisMissouri631471
Nicholas Bossaller
[email protected]
314-806-3921
Melissa Agnew
[email protected]
804-307-8298
Travis Bullock, MD (PRINCIPAL_INVESTIGATOR)
Women's Cancer Center of NevadaLas VegasNevada89169
Thania Escamilla
[email protected]
702-693-6870
Geoffrey Hsieh, MD (PRINCIPAL_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico87131
Cassandra Darley
[email protected]
505 272-9712
Kate Meriwether, MD (PRINCIPAL_INVESTIGATOR)
Novant Health UrogynecologyCharlotteNorth Carolina28210
Alanza Ferguson
[email protected]
704-264-1400
William Porter, MD (PRINCIPAL_INVESTIGATOR)
The Lindner Research Center at The Christ HospitalCincinnatiOhio45219
Sharon Lamping
[email protected]
513-585-2166
Mickey Karram, MD (PRINCIPAL_INVESTIGATOR)
Center for Total Women's HealthLansdalePennsylvania19446
Lorraine Knerr
[email protected]
215-368-1950
Donald DeBrakeleer, MD (PRINCIPAL_INVESTIGATOR)
Center for Pelvic HealthFranklinTennessee37067
Amanda Coffey
[email protected]
(615) 284-4664
Barry Jarnagin, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
Katie Wicklander, CRCC
[email protected]
206-616-8766
Suzette Sutherland, MD (PRINCIPAL_INVESTIGATOR)

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Valley Urogynecology Associates, Inc.· Phoenix, AZUniversity of Arizona College of Medicine· Tucson, AZUrological Research Center Corp· Hialeah, FLWomen's Health Care Associates P.A. dba Rosemark Women Care Specialists· Idaho Falls, IDCMB Research, LLC· Newburgh, INUniversity of Louisville· Louisville, KY

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