NXT Post-Market Clinical Follow-up

Part of paid clinical trials in Hanover, Maryland.

Sponsor
Laborie Medical Technologies Inc.
Study ID
NCT06336304
Status
Recruiting
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Conditions

  • Urinary Bladder, Neurogenic
  • Urinary Bladder, Overactive
  • Urinary Incontinence
  • Urinary Incontinence, Urge
  • Urinary Obstruction

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urodynamic procedure — DIAGNOSTIC_TEST
    Urodynamic procedure

Study Details

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

Key Dates

Start date
Jun 18, 2024
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Pediatric
  • Arm: Male Adult Obstructive
  • Arm: Male Adult Incontinence and/or Overactive Bladder
  • Arm: Female Adult Obstructive
  • Arm: Female Adult Incontinence and/or Overactive Bladder
  • Arm: Adults with Neurological Co-morbidities

Primary Outcome Measure

Assess NXT system performance [ Time Frame: 120 Minutes ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Chesapeake Urology HanoverHanoverMaryland21076
Barbara Kyei
Kaiser Robertson, MD (PRINCIPAL_INVESTIGATOR)
Chesapeake Urology Owing MillsOwing MillsMaryland21117
Seema Shahi
Laura Giusto, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Myanah Keys
Christina Ching, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43212
Maxwell Newton
[email protected]
614-366-9561
Iryna Crescenze, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Olusegun Adelaja
[email protected]
434-924-5783
Jacqueline Zillioux, MD (PRINCIPAL_INVESTIGATOR)

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Chesapeake Urology Hanover· Hanover, MDChesapeake Urology Owing Mills· Owing Mills, MDNationwide Children's Hospital· Columbus, OHOhio State University· Columbus, OHUniversity of Virginia· Charlottesville, VA

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